EBO2 (EBOO) Devices and FDA Status: The Filter, the Ozone Generator, and the Circuit

EBO2 (also called EBOO) runs a patient’s blood through an extracorporeal circuit: tubing, a cartridge where the blood meets a mixture of medical oxygen and ozone, an ozone generator, and at some clinics a light unit [1][2]. We found no FDA approval, clearance, or De Novo authorization for any EBOO system, for an ozone generator meant to treat patients, or for the light units clinics name [3][4]. The filters some circuits use are hemodialyzers [2], cleared for kidney failure and related uses, and each clearance covers only the uses in that filter’s 510(k) [5][6]. This guide takes the parts one at a time, reports what the FDA’s databases returned for the device names clinics give, and sets out how to look up a device yourself. Ozone therapy is not FDA-approved for any condition [7]; the wider question of FDA status is in our guide on whether EBO2 is FDA-approved.

What the FDA has said about each part of the circuit

A part can be cleared while the system around it is not. A 510(k) decision letter finds a device substantially equivalent “for the indications for use stated in the enclosure” [6], and the FDA’s 510(k) page says a new 510(k) is required when a device “is to be marketed for a new or different intended use” [11]. That rule governs how a manufacturer markets its device. It says nothing about EBOO either way, and we draw no conclusion from it about any clinic. The developers of EBOO wrote in 1999 that they had tried a dialysis-type technique first and found semipermeable membranes “unsuitable because they are hydrophilic and vulnerable to O3” [12]; our guide comparing EBOO with dialysis follows that history and the dialyzers now in use.

What an “FDA-cleared filter” claim covers

The FDA’s classification rule for high-permeability hemodialysis systems, 21 CFR 876.5860, identifies them as “intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions” through hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration, and places them in Class II with special controls that include FDA guidance on 510(k)s for hemodialyzers [5]. The product code for high-permeability dialyzers is KDI, and openFDA lists 345 510(k) records under that code, dated December 1978 to July 2026 [6][13]. Cleared filters are therefore common. What matters for a claim is what a particular filter is cleared for.

The one hemodialyzer model that a clinic in our data names is the Elisio 9H. The FDA’s records for Nipro’s ELISIO-H line show:

• K140191, cleared April 14, 2014, added the 09H and 25H sizes to the line. Its indications say hemodialysis with the dialyzer is indicated “for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate”, and that it “may be indicated in the treatment of patients intoxicated with poisons or drugs” [14].
• K260533, cleared March 19, 2026, states that the dialyzers “are intended for hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration in patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate” [6].
• AccessGUDID lists the ELISIO-09H model as in commercial distribution, with the device type “Hollow-fibre haemodialysis dialyser, single-use” [15].

Neither indications statement mentions ozone, oxygenation, or EBOO [14][6]. A clinic that calls a filter like this FDA-cleared would be describing the filter accurately and saying nothing about the rest of the circuit. A regulation states that a 510(k) clearance “does not in any way denote official approval of the device” [16], and the ozone generator and the procedure each need their own answer.

The device names clinics give, and what FDA records showed

As of September 28, 2026, 21 of the 163 clinics in our directory whose EBO2 page we could read named the device or system they use, and their pages use ten names. On October 2, 2026, we searched each name in the 510(k), PMA, registration and listing, and unique device identifier data through openFDA, in the De Novo database and AccessGUDID directly, and in the FDA’s warning letter list [3][4][15][17]. A matching word in an FDA record does not show that a clinic uses that product, and the absence of a match does not show that a device is unregistered or uncleared under some other name.

The O3UV letter itself is consistent with these searches. It found that the firm had not registered and listed for fiscal year 2025 and had sent no information to the FDA’s device identifier database [2], and our searches found no registration and listing record and no device identifier record for O3UV or for either of its product names [3][15]. The letter also names the hemodialyzers the firm bought for its kits, “ABLE® H-200 High Flux Polyethersulfone Disposable Haemodialysers” [2]. We found no 510(k), registration and listing, or device identifier record under that name [3]. The letter does not say who made those filters or whether they were cleared, and its finding about them concerned how the firm controlled its purchasing [2].

Regulators abroad have also acted on devices. In 2025 the New South Wales Health Care Complaints Commission found that a clinic’s ozone generator and UV device were not approved by Australia’s therapeutic goods regulator [18], and Brazil’s health regulator recognizes ozone devices only for skin, dental, and wound-bag uses [19]. Our guide to regulators abroad has the details, and our guide on how to read a clinic’s EBO2 page covers branded names and other wording.

What the FDA has cleared that uses ozone

Eleven 510(k) records returned by openFDA on October 2, 2026, have “ozone” in the device name [13]:

In the dialysis records, ozone disinfects equipment and is then removed [9][20]. The cleared ozone generator’s indications end with the system being rinsed “until the system is residual free of ozone” [9], and the test strips are “designed to indicate the presence of ozone in water used in hemodialysis” [20]. None of the 11 is for exposing a patient or a patient’s blood to ozone [13]. The FDA’s own rule on ozone devices says any device that generates ozone is adulterated or misbranded if it is used “in any medical condition for which there is no proof of safety and effectiveness” [7], and a June 2025 federal indictment alleges that a Virginia physician used “three FDA-unapproved devices that produced medical ozone gas”; the Justice Department notes that charges are only allegations [21].

How to look up a device yourself

1. Get the maker, brand, model, and catalog number from the device’s label, its instructions for use, or the clinic in writing. The FDA’s unique device identifier rule requires a device to carry an identifier on its label and package unless an exception or alternative applies [6].
2. Find the device type in the Product Classification database. It gives the three-letter product code, the device class, and a link to the regulation behind it, if there is one [22][23]. High-permeability dialyzers, for example, are product code KDI under 21 CFR 876.5860, Class II [6]. We found no device type for an ozone generator meant to treat patients [3].
3. Search the 510(k), PMA, and De Novo databases by product code and company name, open the record, and download its summary. The Indications for Use page lists what the device is cleared for [22][6].
4. Search AccessGUDID by brand or model. A record shows the company, the model, the device type, and whether it is in commercial distribution [22][15]. Some records leave the premarket submission field empty: the openFDA copies of the ELISIO-H records we read did, although the line is cleared [3][14]. An empty field is not evidence either way.
5. Search Registration and Listing by proprietary name or company. Where premarket authorization is required, the listing should give the premarket submission number [22], and the FDA says the entry itself does not denote approval, clearance, or authorization [24].
6. Search the Total Product Life Cycle database by product code, which pulls clearances, approvals, adverse event reports, and recalls into one report [22], and search the warning letter list by company and product names [17]. Our guide on whether EBO2 is FDA-approved explains what a warning letter, a close-out letter, and an empty search each mean.

What we could not verify

• The database search forms. The FDA’s 510(k), PMA, and Registration and Listing search pages answered our automated requests with a blank form or an automated check, which we did not try to pass, so those searches ran through openFDA, which says not to rely on it for decisions about medical care and updates its 510(k) data monthly [13]. The De Novo database, AccessGUDID, and the warning letter list answered directly.
• Makers and models. None of the ten names on clinic pages comes with a maker and model number that we could match to a record, apart from the Elisio dialyzer. A kit can contain parts bought from other makers, as the O3UV letter shows [2], so a search by the name on a clinic page can miss the maker of each part.
• How the gas meets the blood in hemodialyzer circuits. We found no FDA document describing how EBOO kits route ozone through a hemodialyzer, and no labeling for any named filter that addresses use with ozone.
• The full 510(k) files. We read the public summaries and decision letters, not the full submissions or each filter’s instructions for use.
• What clinics leave unsaid. As of September 28, 2026, 142 of the 163 clinics whose EBO2 page we could read did not name a device, so the table covers a minority of clinics.
• Anything after October 2, 2026. Records added after our searches will not appear here.

How this guide was made

This guide draws on 26 sources: the FDA’s own records, rules, and database descriptions, the FDA’s July 2025 warning letter, a Justice Department release, two documents from regulators in Australia and Brazil, and two papers by the developers of EBOO. The device names and counts come from our clinic dataset as read on September 28, 2026 (21 named devices among 163 readable pages of 177 listed clinics). The database results come from searches we ran on October 2, 2026, and we keep every query and result on file. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.