FDA product code NFB: Conserver, Oxygen
NFB is the FDA product code for conserver, oxygen. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel. FDA has cleared 71 510(k) submissions under NFB, 3 in the last five years, from 40 different applicants. The average 510(k) review took 116 days (median 88); 170 days on average over the last three years. FDA has posted 6 recalls for NFB devices.
Classification
| Field | Value |
|---|---|
| Device name | Conserver, Oxygen |
| Device class | Class II |
| Regulation | 21 CFR 868.5905 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NFB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 270 |
| 2022 | 2 | 242 |
| 2025 | 1 | 170 |
Compare with all 510(k) review times · Search every NFB clearance
Top NFB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chad Therapeutics, Inc. | 11 | 2007-05-07 |
| Inovo, Inc. | 5 | 2011-12-08 |
| Medical Electronic Devices, Inc. | 5 | 2005-10-24 |
| Salter Labs | 4 | 2016-03-11 |
| Ameriflo Corp. | 2 | 2006-04-19 |
35 more applicants have NFB clearances. See the full list in Caduvo.
Most recent NFB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250322 | Responsive Respiratory | Respond OC Conserving Regulator (130-0800) | 2025-07-24 | 170 |
| K220591 | Dynasthetics, LLC | Proxima | 2022-12-15 | 289 |
| K221014 | Effortless Oxygen, LLC | Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile | 2022-10-17 | 195 |
| K200401 | Incoba Ltd D/B/A Dynaris | Apogee | 2020-11-14 | 270 |
| K151506 | Salter Labs | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | 2016-03-11 | 281 |
Recalls for NFB devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-26.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code NFB?
NFB is the FDA product code for conserver, oxygen. It is a Class II device, regulated under 21 CFR 868.5905 and reviewed by the Anesthesiology panel.
What device class is NFB?
Class II, regulation 21 CFR 868.5905. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFB?
Across 71 cleared submissions the average was 116 days from receipt to decision (median 88).
Which companies have the most NFB clearances?
Chad Therapeutics, Inc. (11); Inovo, Inc. (5); Medical Electronic Devices, Inc. (5); Salter Labs (4); Ameriflo Corp. (2).
Have NFB devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2019-04-26.
Next steps
- Run an FDA pathway report with predicate devices for product code NFB
- Run a recall and safety report across every NFB manufacturer
- Watch product code NFB 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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