FDA product code FPF: Bottle, Hot/Cold Water
FPF is the FDA product code for bottle, hot/cold water. It is a Class I device, regulated under 21 CFR 880.6085 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under FPF. The average 510(k) review took 35 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Bottle, Hot/Cold Water |
| Device class | Class I |
| Regulation | 21 CFR 880.6085 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FPF clearance
Top FPF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Company | 1 | 1979-07-30 |
Most recent FPF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791176 | 3M Company | 3M COLD/HOT WATER BAG AND WRAP | 1979-07-30 | 35 |
Recalls for FPF devices
openFDA lists no recalls for product code FPF.
Frequently asked questions
What is FDA product code FPF?
FPF is the FDA product code for bottle, hot/cold water. It is a Class I device, regulated under 21 CFR 880.6085 and reviewed by the General Hospital panel.
What device class is FPF?
Class I, regulation 21 CFR 880.6085. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FPF?
Across 1 cleared submissions the average was 35 days from receipt to decision (median 35).
Which companies have the most FPF clearances?
3M Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FPF
- Run a recall and safety report across every FPF manufacturer
- Watch product code FPF 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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