510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844176Substantially Equivalent

Premie Comfort Pad Patient & Infant Support Pads

Premie Comfort Products, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844176 is the FDA 510(k) clearance record for PREMIE COMFORT PAD PATIENT & INFANT SUPPORT PADS, a class I device, cleared for Premie Comfort Products on under FDA product code FRP (Holder, Infant Position). FDA records list one 510(k) clearance for Premie Comfort Products. As of , FDA records show no recalls naming K844176.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FRP Holder, Infant Position
Regulation
21 CFR 880.5680
Device class
Class I
Review panel
General Hospital
Applicant
Premie Comfort Products 3745 Purdue St., Dallas TX
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