510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K965107Substantially Equivalent

Medline Admission Kits

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

K965107 is the FDA 510(k) clearance record for MEDLINE ADMISSION KITS, a class II device, cleared for Medline Industries, Inc. on under FDA product code FXX (Mask, Surgical). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K965107.

Clearance record

Decision date
Received
(81 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Medline Industries, Inc. One Medline Pl., Mundelein IL
510(k) summary
Summary
Third party review
No

Clearances, product code FXX

Trailing 12 months
7 clearances under product code FXX in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FXX, trailing twelve months
MonthClearances
December 20252
January 20262
February 20261
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260