510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935220Substantially Equivalent

Core Prevent Mattress Modification

Paladin Medical, Inc., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935220 is the FDA 510(k) clearance record for CORE PREVENT MATTRESS MODIFICATION, a class I device, cleared for Paladin Medical, Inc. on under FDA product code FMW (Cover, Mattress (Medical Purposes)). FDA records list 14 510(k) clearances for Paladin Medical, Inc., from to . As of , FDA records show no recalls naming K935220.

Clearance record

Decision date
Received
(48 days to decision)
Product code
FMW Cover, Mattress (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Applicant
Paladin Medical, Inc. P.O. Box 560, Stillwater MN
510(k) summary
Summary
Third party review
No

Clearances, product code FMW

Trailing 12 months

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

FDA records show no clearances under product code FMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMW, 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