510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963378Substantially Equivalent

Medline Economy Limb Holder,deluxe Limb Holder,cinch-Type Limb Holder,padded Limb Holder,adjustable Limb Holder

MEDLINE INDUSTRIES, LP - Northfield, Mundelein IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963378 is the FDA 510(k) clearance record for MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER, a class I device, cleared for Medline Industries, Inc. on under FDA product code FMQ (Restraint, Protective). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K963378.

Clearance record

Decision date
Received
(63 days to decision)
Product code
FMQ Restraint, Protective
Regulation
21 CFR 880.6760
Device class
Class I
Review panel
General Hospital
Applicant
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Summary
Third party review
No

Clearances, product code FMQ

Trailing 12 months

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

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