FDA product code FOG: Hood, Oxygen, Infant
FOG is the FDA product code for hood, oxygen, infant. It is a Class I device, regulated under 21 CFR 868.5700 and reviewed by the Anesthesiology panel. FDA has cleared 9 510(k) submissions under FOG, from 9 different applicants. The average 510(k) review took 42 days (median 39).
Classification
| Field | Value |
|---|---|
| Device name | Hood, Oxygen, Infant |
| Device class | Class I |
| Regulation | 21 CFR 868.5700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FOG clearance
Top FOG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus America, Inc. | 1 | 1997-11-18 |
| Promedic, Inc. | 1 | 1996-07-15 |
| Advantage Medical Services, Inc. | 1 | 1996-01-30 |
| Jayco Pharmaceuticals | 1 | 1983-03-31 |
| Utah Medical Products, Inc. | 1 | 1979-12-05 |
4 more applicants have FOG clearances. See the full list in Caduvo.
Most recent FOG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973128 | Olympus America, Inc. | OLYMPUS NA-10J-1 ASPIRATION NEEDLE | 1997-11-18 | 89 |
| K962182 | Promedic, Inc. | BURLEW INFANT HOOD | 1996-07-15 | 39 |
| K955482 | Advantage Medical Services, Inc. | SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) | 1996-01-30 | 90 |
| K830781 | Jayco Pharmaceuticals | ENDO-GUARD | 1983-03-31 | 20 |
| K792144 | Utah Medical Products, Inc. | DISPOSA-HOOD | 1979-12-05 | 43 |
Recalls for FOG devices
openFDA lists no recalls for product code FOG.
Frequently asked questions
What is FDA product code FOG?
FOG is the FDA product code for hood, oxygen, infant. It is a Class I device, regulated under 21 CFR 868.5700 and reviewed by the Anesthesiology panel.
What device class is FOG?
Class I, regulation 21 CFR 868.5700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FOG?
Across 9 cleared submissions the average was 42 days from receipt to decision (median 39).
Which companies have the most FOG clearances?
Olympus America, Inc. (1); Promedic, Inc. (1); Advantage Medical Services, Inc. (1); Jayco Pharmaceuticals (1); Utah Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FOG
- Run a recall and safety report across every FOG manufacturer
- Watch product code FOG 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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