FDA product code FOH: Mattress, Water, Temperature Regulated
FOH is the FDA product code for mattress, water, temperature regulated. It is a Class I device, regulated under 21 CFR 880.5560 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under FOH, from 3 different applicants. The average 510(k) review took 41 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Mattress, Water, Temperature Regulated |
| Device class | Class I |
| Regulation | 21 CFR 880.5560 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FOH clearance
Top FOH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmaquest Corp. | 4 | 1981-10-13 |
| Olympic Medical Corp. | 1 | 1995-12-08 |
| Intl. Management Services, Inc. | 1 | 1987-10-13 |
Most recent FOH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954216 | Olympic Medical Corp. | OLYMPIC WARM-BASSINET | 1995-12-08 | 93 |
| K872876 | Intl. Management Services, Inc. | IMSI/EASY FLOAT MATTRESS | 1987-10-13 | 84 |
| K812683 | Pharmaquest Corp. | NEONATE FLEXFLOAT | 1981-10-13 | 21 |
| K812681 | Pharmaquest Corp. | ADULT FLEX FLOAT W/HEATER | 1981-10-08 | 16 |
| K812684 | Pharmaquest Corp. | ADULT FLEXFLOAT | 1981-10-08 | 16 |
Recalls for FOH devices
openFDA lists no recalls for product code FOH.
Frequently asked questions
What is FDA product code FOH?
FOH is the FDA product code for mattress, water, temperature regulated. It is a Class I device, regulated under 21 CFR 880.5560 and reviewed by the General Hospital panel.
What device class is FOH?
Class I, regulation 21 CFR 880.5560. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FOH?
Across 6 cleared submissions the average was 41 days from receipt to decision (median 18).
Which companies have the most FOH clearances?
Pharmaquest Corp. (4); Olympic Medical Corp. (1); Intl. Management Services, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FOH
- Run a recall and safety report across every FOH manufacturer
- Watch product code FOH 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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