Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GJS — Predicate Candidate Screening
127 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
357 days90th percentile
127clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | 2025-10-24 | 28 | 0 |
| K251564 | microINR System | Iline Microsystems, S.L. | 2025-07-21 | 60 | 0 |
| K243543 | microINR System | Iline Microsystems, S.L. | 2025-02-27 | 104 | 0 |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | 2024-03-15 | 358 | 0 |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | 2023-07-14 | 528 | 0 |
| K231711 | microINR System | Iline Microsystems, S.L. | 2023-07-11 | 29 | 0 |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | 2022-12-23 | 589 | 0 |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Pati | Coagusense, Inc. | 2022-10-05 | 399 | 0 |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | 2022-08-16 | 299 | 0 |
| K201185 | microINR System | Iline Microsystems, S.L. | 2020-12-18 | 231 | 0 |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019-02-21 | 92 | 1 |
| K180780 | microINR System | Iline Microsystems, S.L. | 2019-01-25 | 305 | 0 |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | 2018-04-19 | 35 | 1 |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics | 2018-04-19 | 34 | 0 |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | 2017-12-25 | 269 | 1 |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT Control | Siemens Healthcare Diagnostics | 2016-09-30 | 442 | 0 |
| K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | Instrumentation Laboratory CO | 2014-01-22 | 145 | 0 |
| K122584 | HEMOSIL READIPLAS TIN | Instrumentation Laboratory CO | 2013-03-24 | 212 | 2 |
| K110212 | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP | Alere San Diego, Inc (Formally Biosite Incorporate | 2012-05-01 | 462 | 5 |
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Biosite Incorporated | 2010-06-11 | 256 | 7 |
| K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | Coagusense, Inc. | 2010-04-07 | 174 | 1 |
| K093460 | COAGUCHEK XS PRO SYSTEM | Roche Diagnostics | 2010-03-18 | 132 | 3 |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Roche Diagnostics Corp. | 2010-03-05 | 162 | 0 |
| K072920 | HANDHELD BASE UNIT | Roche Diagnostics Corp. | 2008-01-31 | 108 | 0 |
| K072727 | INRATIO 2 PT MONITORING SYSTEM | Hemosense, Inc. | 2007-10-26 | 30 | 6 |
| K070005 | HEMOSIL RECOMBIPLASTIN 2G | Instrumentation Laboratory CO | 2007-08-15 | 224 | 1 |
| K071041 | COAGUCHEK XS PLUS SYSTEM | Roche Diagnostics | 2007-05-11 | 29 | 3 |
| K062925 | COAGUCHEK XS SYSTEM | Roche Diagnostics Corp. | 2007-01-29 | 123 | 4 |
| K060978 | COAGUCHEK XS SYSTEM | Roche Diagnostics | 2006-08-11 | 123 | 3 |
| K060931 | HEMOSIL PT-FIBRINOGEN HS PLUS | Instrumentation Laboratory CO | 2006-05-02 | 27 | 1 |
| K052124 | ACTICLOT, MODEL 824 | American Diagnostica, Inc. | 2005-10-17 | 73 | 1 |
| K043184 | HEMOSIL RECOMBIPLASTIN | Instrumentation Laboratory CO | 2004-12-22 | 35 | 1 |
| K040296 | PHOSPHOPLASTIN RL | R2 Diagnostics, Inc. | 2004-05-24 | 105 | 0 |
| K030845 | COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING | Roche Diagnostics Corp. | 2003-05-22 | 66 | 1 |
| K021190 | PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 | Roche Diagnostics Corp. | 2002-10-25 | 193 | 1 |
| K021923 | INRATIO SELF-TEST | Hemosense, Inc. | 2002-10-24 | 135 | 4 |
| K020831 | PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MO | Roche Diagnostics Corp. | 2002-10-24 | 224 | 0 |
| K022922 | HARMONY INR MONITORING SYSTEM | Lifescan, Inc. | 2002-09-30 | 26 | 0 |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | Vital Scientific N.V. | 2002-05-15 | 61 | 0 |
| K020355 | I-STAT PROTHROMBIN TIME TEST | I-Stat Corporation | 2002-05-14 | 99 | 5 |
| K020679 | INRATIO | Hemosense, Inc. | 2002-05-06 | 63 | 6 |
| K013155 | DADE THROMBOPLASTIN C PLUS | Dade Behring, Inc. | 2002-01-18 | 119 | 0 |
| K012768 | HEMOSIL RECOMBI PLASTIN | Instrumentation Laboratory CO | 2001-09-18 | 32 | 0 |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | International Technidyne Corp. | 2001-07-02 | 124 | 3 |
| K001699 | RUBICON PROTHROMBIN TIME MONITORING SYSTEM | Lifescan, Inc. | 2001-05-15 | 347 | 0 |
| K003870 | THROMBOREL S | Dade Behring, Inc. | 2001-02-20 | 67 | 0 |
| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D | Pacific Hemostasis | 2000-02-18 | 77 | 2 |
| K994006 | AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE | Avocet Medical, Inc. | 2000-02-03 | 71 | 0 |
| K991286 | AVOCET ACUSURE SYSTEM | Avocet Medical, Inc. | 1999-11-18 | 217 | 0 |
| K992492 | PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS F | Roche Diagnostics Corp. | 1999-11-02 | 99 | 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