510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012597Substantially Equivalent

Sterilmed Reprocessed Compression Sleeves

Sterilmed Inc, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012597 is the FDA 510(k) clearance record for STERILMED REPROCESSED COMPRESSION SLEEVES, a class II device, cleared for Sterilmed, Inc. on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show no recalls naming K012597.

Clearance record

Decision date
Received
(185 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Sterilmed, Inc. 11400 73rd Ave. N, Maple Grove MN
510(k) summary
Summary
Third party review
No

Clearances, product code JOW

Trailing 12 months
8 clearances under product code JOW 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 JOW, trailing twelve months
MonthClearances
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20261
August 20261
September 20261
October 20260
November 20260