FDA product code FNM: Mattress, Air Flotation, Alternating Pressure
FNM is the FDA product code for mattress, air flotation, alternating pressure. It is a Class II device, regulated under 21 CFR 880.5550 and reviewed by the General Hospital panel. FDA has cleared 102 510(k) submissions under FNM, from 68 different applicants. The average 510(k) review took 134 days (median 94). FDA has posted 13 recalls for FNM devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mattress, Air Flotation, Alternating Pressure |
| Device class | Class II |
| Regulation | 21 CFR 880.5550 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FNM clearance
Top FNM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Span-America Medical Systems, Inc. | 8 | 1998-02-20 |
| Kinetic Concepts, Inc. | 8 | 1997-11-18 |
| Huntleigh Technology, Inc. | 5 | 1989-03-29 |
| Lumex, Inc. | 3 | 1997-01-10 |
| 9th Wave, Inc. | 3 | 1997-01-07 |
63 more applicants have FNM clearances. See the full list in Caduvo.
Most recent FNM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973169 | Span-America Medical Systems, Inc. | PRESSURE GUARD SITE SELECT (A) | 1998-02-20 | 179 |
| K974319 | Wheelchairs of Kansas | MIGHTY AIR | 1998-01-22 | 66 |
| K972022 | Cardio Systems, Inc. | ZAK-2000 | 1998-01-22 | 234 |
| K974070 | Physio Designs, Inc. | PHYSIO/1000 | 1998-01-06 | 70 |
| K972549 | Kinetic Concepts, Inc. | SIMPULSE | 1997-11-18 | 133 |
Recalls for FNM devices
13 product recalls in 10 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-01-21.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FNM?
FNM is the FDA product code for mattress, air flotation, alternating pressure. It is a Class II device, regulated under 21 CFR 880.5550 and reviewed by the General Hospital panel.
What device class is FNM?
Class II, regulation 21 CFR 880.5550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNM?
Across 102 cleared submissions the average was 134 days from receipt to decision (median 94).
Which companies have the most FNM clearances?
Span-America Medical Systems, Inc. (8); Kinetic Concepts, Inc. (8); Huntleigh Technology, Inc. (5); Lumex, Inc. (3); 9th Wave, Inc. (3).
Have FNM devices been recalled?
Yes: 13 product recalls across 10 recall events; the most recent began 2026-01-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FNM
- Run a recall and safety report across every FNM manufacturer
- Watch product code FNM 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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