Product code FRP— General Hospital
CUDDLE UP PILLOW
- Classification name
- Holder, Infant Position
- Device class
- Class 1
- Regulation
- 21 CFR 880.5680
- Advisory panel
- General Hospital
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code FRP
FDA has cleared devices under product code FRP between 1981 and 2009, filed by 13 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2009
- 2006
- 2005
- 2004
- 2001
- 1995
- 1994
- 1991
- 1989
- 1985
- 1981
Top applicants under product code FRP
Recent clearances under product code FRP
- K082367 — INFANT SLEEP BEANIE
- K090284 — RES-Q INFANT WEDGE AND SLING
- K062143 — KOZY COMFORT INFANT POSITIONER
- K060986 — HEAD BED
- K051300 — ROBIN HOOD VEST
- K041996 — NIGHTFORM
- K003511 — KENDALL-LTP TURNER SAVE-A-LINE
- K943017 — NEONATAL RESTRAINT AND COMFORT SYSTEMS
- K932636 — THE TUCKER SLING
- K905629 — PEDICRAFT INFANT REFLUX WEDGE
- K905630 — INFANT REFLUX SLING
- K882544 — CUDDLE UP PILLOW
- K844176 — PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS
- K810609 — PEDIATRIC POSITION HOLDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.