510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082367Substantially Equivalent

Infant Sleep Beanie

Life Innovations, LLC, Wellington CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082367 is the FDA 510(k) clearance record for INFANT SLEEP BEANIE, a class I device, cleared for Life Innovations, LLC on under FDA product code FRP (Holder, Infant Position). FDA records list one 510(k) clearance for Life Innovations, LLC. As of , FDA records show no recalls naming K082367.

Clearance record

Decision date
Received
(298 days to decision)
Product code
FRP Holder, Infant Position
Regulation
21 CFR 880.5680
Device class
Class I
Review panel
General Hospital
Applicant
Life Innovations, LLC P.O. Box 148, Wellington CO
510(k) summary
Summary PDF
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