Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JPA — Predicate Candidate Screening
181 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
240 days90th percentile
181clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253658 | STA Satellite Max® | Diagnostica Stago, Inc. | 2026-04-27 | 158 | 0 |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | Sysmex America, Inc. | 2025-06-02 | 63 | 0 |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartr | Haemonetics | 2025-04-30 | 28 | 0 |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartr | Haemonetics Corporation | 2025-01-15 | 30 | 0 |
| K232018 | Citrated: K, KH, RTH, FFH | Haemonetics Corporation | 2024-03-29 | 266 | 0 |
| K233790 | ACL TOP 970 CL | Instrumentation Laboratory | 2023-12-29 | 31 | 0 |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL | Instrumentation Laboratory CO | 2023-09-29 | 506 | 0 |
| K212183 | STA R Max 3, STA Compact Max 3 | Diagnostica Stago S.A.S | 2023-06-07 | 694 | 0 |
| K201440 | ROTEM sigma Thromboelastometry System | Tem Innovations GmbH | 2022-07-08 | 767 | 0 |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotti | Accriva Diagnostics, Inc. | 2021-12-29 | 518 | 1 |
| K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | 2019-11-22 | 22 | 0 |
| K183390 | QNext and DG-PT | Diagnostic Grifols, S.A. | 2019-08-21 | 258 | 0 |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay C | Haemonetics Corporation | 2019-05-09 | 175 | 0 |
| K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Cal | Sekisui Medical Co., Ltd. | 2018-05-09 | 219 | 0 |
| K172286 | Automated Blood Coagulation Analyzer CS-2500 | Siemens Healthcare Diagnostic Products GmbH | 2017-12-18 | 143 | 0 |
| K172333 | Sysmex CS-5100 | Siemens Healthcare Diagnostics Products GmbH | 2017-10-31 | 90 | 0 |
| K160502 | TEG 6s Hemostasis System | Haemonetics Corporation | 2017-04-19 | 421 | 0 |
| K170314 | ACL AcuStar | Instrumentation Laboratory CO | 2017-03-03 | 30 | 0 |
| K162688 | Sysmex CS-2100i | Siemens Healthcare Diagnostics Products GmbH | 2016-12-26 | 90 | 0 |
| K162420 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostics Products GmbH | 2016-12-12 | 104 | 0 |
| K161317 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostics Products GmbH | 2016-09-02 | 114 | 0 |
| K161312 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | Siemens Healthcare Diagnostics Products GmbH | 2016-09-01 | 114 | 0 |
| K151259 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | Siemens Healthcare Diagnostics Products GmbH | 2016-01-26 | 259 | 0 |
| K150678 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostic Products GmbH | 2016-01-11 | 301 | 0 |
| K151867 | STA R MAX | Diagnostica Stago S.A.S | 2015-08-07 | 29 | 1 |
| K150041 | CORA (Coagulation Resonance Analysis) System | Coramed Technologies, LLC | 2015-06-26 | 168 | 0 |
| K130090 | STA COMPACT MAX | Diagnostica Stago, Incorporated | 2013-02-12 | 29 | 1 |
| K101533 | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET | Tem Innovations GmbH | 2011-08-10 | 433 | 1 |
| K083842 | ROTEM DELTA THROMBOELASTOMETRY SYSTEM | Pentapharm GmbH | 2010-03-23 | 454 | 1 |
| K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | Diagnostica Stago, Inc. | 2009-12-22 | 76 | 1 |
| K093001 | STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MU | Diagnostica Stago, Incorporated | 2009-12-18 | 81 | 0 |
| K083896 | DESTINY MAX COAGULATION ANALYZER | Trinity Biotech | 2009-07-02 | 185 | 0 |
| K083518 | ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIME | Instrumentation Laboratory CO | 2009-03-13 | 107 | 0 |
| K083175 | BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTRO | Siemens Healthcare Diagnostics | 2009-01-26 | 90 | 0 |
| K083159 | BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONT | Siemens Healthcare Diagnostics | 2009-01-26 | 91 | 0 |
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | Diagnostica Stago, Inc. | 2008-12-12 | 126 | 2 |
| K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | Diagnostica Stago, Inc. | 2008-10-10 | 25 | 0 |
| K071265 | SMARTCHECK INR SYSTEM | Inverness Medical Innovations, Inc. | 2007-11-30 | 207 | 0 |
| K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | Helena Laboratories | 2006-05-10 | 27 | 0 |
| K060162 | ACL ELITE; ACL ELITE PRO | Instrumentation Laboratory CO | 2006-02-21 | 29 | 5 |
| K051030 | COAG-A-MATE MTX III | bioMerieux, Inc. | 2005-12-23 | 245 | 0 |
| K050053 | HEMORAM/AGGRAM ANALYZER | Helena Laboratories | 2005-07-11 | 182 | 0 |
| K050243 | IMMEDIA PROTHROMBIN TIME SYSTEM | Farallon Medial, Inc. | 2005-06-06 | 124 | 0 |
| K050513 | MDA B.30 | bioMerieux, Inc. | 2005-04-01 | 31 | 0 |
| K050016 | HEMOCHRON SIGNATURE ELITE | International Technidyne Corp. | 2005-02-10 | 37 | 0 |
| K040359 | HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 | Instrumentation Laboratory CO | 2004-03-19 | 35 | 0 |
| K033137 | POTENS + | Wada, Inc. | 2003-12-08 | 69 | 0 |
| K030818 | HEMOCHRON RESPONSE/SYSTEM | International Technidyne Corp. | 2003-04-02 | 19 | 0 |
| K023141 | MODIFICATION TO STANDARD HUMAN PLASMA | Dade Behring, Inc. | 2003-01-16 | 118 | 0 |
| K021162 | AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION | Sigma Diagnostics, Inc. | 2002-08-30 | 141 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda