Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JOZ — Predicate Candidate Screening
38 FDA 510(k) clearances under this product code; the 50 most recent screened below.
135 daysmedian FDA review time
302 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191364 | T-TAS 01 Total Thrombus-formation Analysis System Instrument | Fujimori Kogyo, Co., Ltd. | 2020-02-14 | 268 | 0 |
| K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | 2019-03-29 | 269 | 0 |
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | 2017-04-05 | 135 | 0 |
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Plat | Chrono-Log Corp. | 2016-12-02 | 204 | 0 |
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFY | Accumetrics, Inc. | 2015-07-24 | 420 | 1 |
| K140893 | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET M | Coramed Technologies, LLC | 2015-01-03 | 270 | 0 |
| K122162 | AGGREGUIDE | Aggredyne, Inc. | 2013-12-20 | 518 | 0 |
| K103555 | MULTIPLATE 5.0 AGGREGOMETER | Verum Diagnostica GmbH | 2012-07-27 | 602 | 0 |
| K060489 | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | Dade Behring, Inc. | 2006-07-21 | 147 | 0 |
| K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | Chrono-Log Corp. | 2005-10-14 | 252 | 0 |
| K051231 | VERIFYNOW-P2Y12 ASSAY | Accumetrics, Inc. | 2005-08-05 | 84 | 3 |
| K042423 | VERIFYNOW-ASPIRIN ASSAY | Accumetrics, Inc. | 2004-10-06 | 29 | 0 |
| K041502 | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | Haemoscope Corp. | 2004-09-01 | 86 | 0 |
| K032951 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | Chrono-Log Corp. | 2004-04-02 | 193 | 0 |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Helena Laboratories | 2003-02-14 | 98 | 0 |
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA | Accumetrics, Inc. | 2002-06-12 | 302 | 1 |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY | Accumetrics, Inc. | 2002-05-16 | 197 | 2 |
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | Accumetrics, Inc. | 2001-10-16 | 167 | 2 |
| K012723 | PLATELETWORKS | Helena Laboratories | 2001-09-28 | 44 | 0 |
| K002885 | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA | Dade Behring, Inc. | 2001-06-21 | 279 | 0 |
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTI | Accumetrics, Inc. | 1999-12-20 | 145 | 3 |
| K990398 | PLATELETWORKS | Array Medical, Inc. | 1999-12-01 | 295 | 0 |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPH | Dade Intl., Inc. | 1997-11-17 | 280 | 0 |
| K962426 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 | Chrono-Log Corp. | 1996-10-22 | 120 | 0 |
| K954997 | CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT | Centocor, Inc. | 1996-01-24 | 84 | 0 |
| K940792 | AGGRO/LINK VW COFACTOR SOFTWARE | Chrono-Log Corp. | 1994-10-13 | 233 | 0 |
| K862302 | BLOOD PLATELET ASSAY METHOD & APPARATUS | Bellhouse Medical, Inc. | 1986-07-31 | 44 | 0 |
| K851669 | MONITOR IV PLUS | Helena Laboratories | 1985-07-23 | 91 | 0 |
| K800432 | HELENA RISTOCETIN | Helena Laboratories | 1980-03-25 | 27 | 0 |
| K800146 | PLATELET AGGREGATION REAGENTS | Pacific Hemostasis | 1980-02-05 | 14 | 0 |
| K791577 | ELVI 840 AGGREGOMETER | Volu Sol Medical Industries | 1979-09-17 | 31 | 0 |
| K790769 | BETA/PAK | Bio/Data Corp. | 1979-05-03 | 14 | 0 |
| K781693 | COLLAGENREAGENT HORM | Hormon-Chemie Munchem Gmch | 1978-12-07 | 64 | 0 |
| K781807 | REAGENT, FIREFLY #395 | Chrono-Log Corp. | 1978-11-22 | 28 | 0 |
| K780285 | SOLUBLE COLLAGEN | General Diagnostics | 1978-03-30 | 37 | 0 |
| K780047 | PLATELET AGGREGATING REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-02 | 52 | 0 |
| K770395 | THROMBO-CETIN (RISTOCETIN) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-03-21 | 21 | 0 |
| K760893 | AGGRECETIN | Bio/Data Corp. | 1977-01-12 | 77 | 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