FDA product code FPP: Stretcher, Hand-Carried
FPP is the FDA product code for stretcher, hand-carried. It is a Class I device, regulated under 21 CFR 880.6900 and reviewed by the General Hospital panel. FDA has cleared 39 510(k) submissions under FPP, from 32 different applicants. The average 510(k) review took 89 days (median 63). FDA has posted 12 recalls for FPP devices.
Classification
| Field | Value |
|---|---|
| Device name | Stretcher, Hand-Carried |
| Device class | Class I |
| Regulation | 21 CFR 880.6900 |
| 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 FPP clearance
Top FPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. Murphy Ent., Inc. | 3 | 1991-04-01 |
| Araluen, Inc. | 3 | 1981-05-13 |
| Minto Research & Development, Inc. | 2 | 1990-10-12 |
| Dyna Corp. | 2 | 1990-04-23 |
| Skedco, Inc. | 2 | 1990-01-11 |
27 more applicants have FPP clearances. See the full list in Caduvo.
Most recent FPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030283 | Prism Enterprises, Inc. | BABY POD | 2003-04-22 | 85 |
| K942356 | Montery Bay Corp. | MED-EVAC-4 MEDICAL EVACUATION STRETCHER | 1994-07-19 | 63 |
| K940130 | Stryker Corp. | STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER | 1994-03-10 | 66 |
| K940245 | Evacu Technologies, Inc. | EVACU-SLED | 1994-02-28 | 40 |
| K924275 | Dms | RESTRAINING STRETCHER | 1993-07-27 | 336 |
Recalls for FPP devices
12 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-06-29.
Frequently asked questions
What is FDA product code FPP?
FPP is the FDA product code for stretcher, hand-carried. It is a Class I device, regulated under 21 CFR 880.6900 and reviewed by the General Hospital panel.
What device class is FPP?
Class I, regulation 21 CFR 880.6900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FPP?
Across 39 cleared submissions the average was 89 days from receipt to decision (median 63).
Which companies have the most FPP clearances?
W. Murphy Ent., Inc. (3); Araluen, Inc. (3); Minto Research & Development, Inc. (2); Dyna Corp. (2); Skedco, Inc. (2).
Have FPP devices been recalled?
Yes: 12 product recalls across 6 recall events; the most recent began 2016-06-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FPP
- Run a recall and safety report across every FPP manufacturer
- Watch product code FPP 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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