510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882544Substantially Equivalent

Cuddle Up Pillow

Ohio Medical Instrument Co., Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882544 is the FDA 510(k) clearance record for CUDDLE UP PILLOW, a class I device, cleared for Ohio Medical Instrument Co., Inc. on under FDA product code FRP (Holder, Infant Position). FDA records list 19 510(k) clearances for Ohio Medical Instrument Co., Inc., from to . As of , FDA records show no recalls naming K882544.

Clearance record

Decision date
Received
(224 days to decision)
Product code
FRP Holder, Infant Position
Regulation
21 CFR 880.5680
Device class
Class I
Review panel
General Hospital
Applicant
Ohio Medical Instrument Co., Inc. 3924 Virginia Ave., Cincinnati OH
Third party review
No

Clearances, product code FRP

Trailing 12 months

FDA records hold no clearances under product code FRP in the trailing twelve months.

FDA records show no clearances under product code FRP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260