Atlas FDA

EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM

FDA 510(k) clearance K101533 · decided 2011-08-10

Clearance details

K-number
K101533
Device name
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
Applicant
Tem Innovations GmbH
Decision
Substantially Equivalent
Date received
2010-06-03
Decision date
2011-08-10
Days to decision
433 days
Clearance type
Traditional
Product code
JPA
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Munich, Bavaria/Upper Bavaria, DE
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Tem Innovations GmbH

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STA Satellite Max® (K253658)Diagnostica Stago, Inc.2026-04-27
Automated Blood Coagulation Analyzer CN-Series (CN-6000) (K250965)Sysmex America, Inc.2025-06-02
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K251024)Haemonetics2025-04-30
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858)Haemonetics Corporation2025-01-15
Citrated: K, KH, RTH, FFH (K232018)Haemonetics Corporation2024-03-29
ACL TOP 970 CL (K233790)Instrumentation Laboratory2023-12-29
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM (K221359)Instrumentation Laboratory CO2023-09-29
STA R Max 3, STA Compact Max 3 (K212183)Diagnostica Stago S.A.S2023-06-07
ROTEM sigma Thromboelastometry System (K201440)Tem Innovations GmbH2022-07-08
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 (K202101)Accriva Diagnostics, Inc.2021-12-29
Hemochron Signature Elite (K193041)Accriva Diagnostics, Inc.2019-11-22
QNext and DG-PT (K183390)Diagnostic Grifols, S.A.2019-08-21

Recalls involving this device

RecordFirmDate
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovati recall (Z-1379-2015)TEM Systems Inc2015-04-03