FDA product code ONT: N95 Respirator With Antimicrobial/Antiviral Agent
ONT is the FDA product code for n95 respirator with antimicrobial/antiviral agent. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under ONT, from 3 different applicants. The average 510(k) review took 325 days (median 250).
Definition
A single use, disposable, NIOSH-approved respirator intended for occupational use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological particulates and has an added antimicrobial and/or antiviral agent which kills specified pathogens under specified contact conditions.
Classification
| Field | Value |
|---|---|
| Device name | N95 Respirator With Antimicrobial/Antiviral Agent |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ONT clearance
Top ONT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nexera Medical, Inc. | 3 | 2015-12-29 |
| Glaxosmithkline Consumer Healthcare | 2 | 2010-05-10 |
| Filligent Limited | 1 | 2013-03-18 |
Most recent ONT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150729 | Nexera Medical, Inc. | SpectraShield 9500 Surgical N95 Respirator | 2015-12-29 | 284 |
| K122702 | Filligent Limited | BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR | 2013-03-18 | 195 |
| K120244 | Nexera Medical, Inc. | SPECTRASHIELD 9500 SURGICAL N95 RESPIRATOR | 2012-07-05 | 160 |
| K090414 | Nexera Medical, Inc. | SPECTRASHIELD 9500 SURGICAL MASK | 2011-02-24 | 736 |
| K093161 | Glaxosmithkline Consumer Healthcare | ACTIPROTECT UF N95 RESPIRATOR | 2010-05-10 | 216 |
Recalls for ONT devices
openFDA lists no recalls for product code ONT.
Frequently asked questions
What is FDA product code ONT?
ONT is the FDA product code for n95 respirator with antimicrobial/antiviral agent. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is ONT?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONT?
Across 6 cleared submissions the average was 325 days from receipt to decision (median 250).
Which companies have the most ONT clearances?
Nexera Medical, Inc. (3); Glaxosmithkline Consumer Healthcare (2); Filligent Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONT
- Run a recall and safety report across every ONT manufacturer
- Watch product code ONT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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