510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191364Substantially Equivalent

T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01

Fujimori Kogyo, Co., Ltd., Shinjuku, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191364 is the FDA 510(k) clearance record for T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01, a class II device, cleared for Fujimori Kogyo, Co., Ltd. on under FDA product code JOZ (System, Automated Platelet Aggregation). FDA records list one 510(k) clearance for Fujimori Kogyo, Co., Ltd. As of , FDA records show no recalls naming K191364.

Clearance record

Decision date
Received
(268 days to decision)
Product code
JOZ System, Automated Platelet Aggregation
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Applicant
Fujimori Kogyo, Co., Ltd. Shinjuku First W. 1-23-7 Nishi-Shinjuku, Shinjuku, Tokyo, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOZ

Trailing 12 months

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

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