510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053188Substantially Equivalent

Reprocessed Baloon Inflation Device

Sterilmed Inc, Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053188 is the FDA 510(k) clearance record for REPROCESSED BALOON INFLATION DEVICE, a class II device, cleared for Sterilmed, Inc. on under FDA product code NKU (Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed). FDA records list 65 510(k) clearances for Sterilmed, Inc., from to . As of , FDA records show one recall naming K053188.

Clearance record

Decision date
Received
(170 days to decision)
Product code
NKU Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Sterilmed, Inc. 11400 73rd Ave. N, Maple Grove MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKU

Trailing 12 months

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

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