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
K161312Substantially Equivalent

Sysmex Automated Blood Coagulation Analyzer CS-2100i

Siemens Healthcare Diagnostics Products Limited, Marburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161312 is the FDA 510(k) clearance record for Sysmex Automated Blood Coagulation Analyzer CS-2100i, a class II device, cleared for Siemens Healthcare Diagnostics Products GmbH on under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies). FDA records list 23 510(k) clearances for Siemens Healthcare Diagnostics Products GmbH, from to . As of , FDA records show no recalls naming K161312.

Clearance record

Decision date
Received
(114 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
Siemens Healthcare Diagnostics Products GmbH Emil-Von-Behring-Str. 76, Marburg, DE
510(k) summary
Summary PDF
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