510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840553Substantially Equivalent

Hemastaph

Remel Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840553 is the FDA 510(k) clearance record for HEMASTAPH, a class I device, cleared for Remel Co. on under FDA product code JTL (Plasma, Coagulase, Human, Horse And Rabbit). FDA records list 51 510(k) clearances for Remel Co., from to . As of , FDA records show no recalls naming K840553.

Clearance record

Decision date
Received
(65 days to decision)
Product code
JTL Plasma, Coagulase, Human, Horse And Rabbit
Regulation
21 CFR 866.2160
Device class
Class I
Review panel
Microbiology
Applicant
Remel Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTL

Trailing 12 months

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

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