FRP
14 FDA 510(k) clearances · Product code
92 daysmedian time to decision
238 days90th percentile
14clearances measured
FDA profile
- Official device name
- Holder, Infant Position
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5680
- Medical specialty
- General Hospital
- Flags
- GMP exempt · Third-party review eligible
- Adverse events (MAUDE)
- 1999: 1 · 2001: 1 · 2002: 1 · 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| INFANT SLEEP BEANIE (K082367) | Life Innovations, LLC | 2009-06-12 |
| RES-Q INFANT WEDGE AND SLING (K090284) | Cr Enterprises, LLC | 2009-06-05 |
| KOZY COMFORT INFANT POSITIONER (K062143) | Alfred E Mann Inst. For Biomedical Engineering | 2006-10-24 |
| HEAD BED (K060986) | Steven H. Warnock, M.D. | 2006-07-11 |
| ROBIN HOOD VEST (K051300) | Kamber Corporation | 2005-12-08 |
| NIGHTFORM (K041996) | Plastic Surgery Solutions, LLC | 2004-08-03 |
| KENDALL-LTP TURNER SAVE-A-LINE (K003511) | The Ludlow Company LP | 2001-01-24 |
| NEONATAL RESTRAINT AND COMFORT SYSTEMS (K943017) | K.Bowmed, Inc. | 1995-01-19 |
| THE TUCKER SLING (K932636) | Tucker Designs, Ltd. | 1994-01-26 |
| INFANT REFLUX SLING (K905630) | Pedicraft, Inc. | 1991-03-13 |
| PEDICRAFT INFANT REFLUX WEDGE (K905629) | Pedicraft, Inc. | 1991-03-13 |
| CUDDLE UP PILLOW (K882544) | Ohio Medical Instrument Co., Inc. | 1989-01-31 |
| PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS (K844176) | Premie Comfort Products | 1985-01-23 |
| PEDIATRIC POSITION HOLDER (K810609) | Kaye Products, Inc. | 1981-03-20 |
Track FRP automatically
Every clearance here is in the API, with alerts when new ones post.