510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953500Substantially Equivalent

Hemo-Barrier

Asia Dynamics Inc., Niles IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953500 is the FDA 510(k) clearance record for HEMO-BARRIER, a class I device, cleared for Asia Dynamics, Inc. on under FDA product code KMF (Bandage, Liquid). FDA records list 4 510(k) clearances for Asia Dynamics, Inc., from to . As of , FDA records show no recalls naming K953500.

Clearance record

Decision date
Received
(182 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Asia Dynamics, Inc. 5745 W. Howard St., Niles IL
510(k) summary
Summary
Third party review
No

Clearances, product code KMF

Trailing 12 months

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

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