FDA product code FRP: Holder, Infant Position
FRP is the FDA product code for holder, infant position. It is a Class I device, regulated under 21 CFR 880.5680 and reviewed by the General Hospital panel. FDA has cleared 14 510(k) submissions under FRP, from 13 different applicants. The average 510(k) review took 131 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Holder, Infant Position |
| Device class | Class I |
| Regulation | 21 CFR 880.5680 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| GMP exempt | Yes |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FRP clearance
Top FRP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pedicraft, Inc. | 2 | 1991-03-13 |
| Life Innovations, LLC | 1 | 2009-06-12 |
| Cr Enterprises, LLC | 1 | 2009-06-05 |
| Alfred E Mann Inst. For Biomedical Engineering | 1 | 2006-10-24 |
| Steven H. Warnock, M.D. | 1 | 2006-07-11 |
8 more applicants have FRP clearances. See the full list in Caduvo.
Most recent FRP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082367 | Life Innovations, LLC | INFANT SLEEP BEANIE | 2009-06-12 | 298 |
| K090284 | Cr Enterprises, LLC | RES-Q INFANT WEDGE AND SLING | 2009-06-05 | 120 |
| K062143 | Alfred E Mann Inst. For Biomedical Engineering | KOZY COMFORT INFANT POSITIONER | 2006-10-24 | 89 |
| K060986 | Steven H. Warnock, M.D. | HEAD BED | 2006-07-11 | 92 |
| K051300 | Kamber Corporation | ROBIN HOOD VEST | 2005-12-08 | 204 |
Recalls for FRP devices
openFDA lists no recalls for product code FRP.
Frequently asked questions
What is FDA product code FRP?
FRP is the FDA product code for holder, infant position. It is a Class I device, regulated under 21 CFR 880.5680 and reviewed by the General Hospital panel.
What device class is FRP?
Class I, regulation 21 CFR 880.5680. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRP?
Across 14 cleared submissions the average was 131 days from receipt to decision (median 91).
Which companies have the most FRP clearances?
Pedicraft, Inc. (2); Life Innovations, LLC (1); Cr Enterprises, LLC (1); Alfred E Mann Inst. For Biomedical Engineering (1); Steven H. Warnock, M.D. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FRP
- Run a recall and safety report across every FRP manufacturer
- Watch product code FRP 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times