510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012574Substantially Equivalent

Reprocessed Femoral Compression Device

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

K012574 is the FDA 510(k) clearance record for REPROCESSED FEMORAL COMPRESSION DEVICE, a class II device, cleared for Sterilmed, Inc. on under FDA product code NMF (Clamp, Vascular, Reprocessed). FDA's definition for product code NMF reads: "Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show one recall naming K012574.

Clearance record

Decision date
Received
(343 days to decision)
Product code
NMF Clamp, Vascular, Reprocessed
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Sterilmed, Inc. 11400 73rd Ave. N Suite 100, Maple Grove MN
510(k) summary
Summary
Third party review
No

Clearances, product code NMF

Trailing 12 months

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

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