510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050053Substantially Equivalent

Hemoram/aggram Analyzer

Helena Laboratories, Corp., Beaumont TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K050053 is the FDA 510(k) clearance record for HEMORAM/AGGRAM ANALYZER, a class II device, cleared for Helena Laboratories on under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K050053.

Clearance record

Decision date
Received
(182 days to decision)
Product code
JPA System, Multipurpose For In Vitro Coagulation Studies
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Helena Laboratories 1530 Lindbergh Dr., Beaumont TX
510(k) summary
Statement
Third party review
No

Clearances, product code JPA

Trailing 12 months
1 clearance under product code JPA in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JPA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260