Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JBP — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
192 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System wit | Sienco, Inc. | 2023-01-04 | 30 | 0 |
| K062604 | RAPIDTEG TEG-ACT TEST | Haemoscope Corp. | 2007-01-31 | 152 | 0 |
| K032952 | AIACT KIT | Sienco, Inc. | 2003-12-12 | 81 | 0 |
| K023582 | I-STAT KAOLIN ACT TEST | I-Stat Corporation | 2003-09-08 | 319 | 2 |
| K020914 | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 | Helena Laboratories | 2002-05-23 | 63 | 0 |
| K013078 | ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 575 | Helena Laboratories | 2002-01-10 | 118 | 0 |
| K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WIT | Sienco, Inc. | 2000-08-31 | 15 | 0 |
| K994194 | (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT | Cardiovascular Diagnostics, Inc. | 2000-03-28 | 106 | 0 |
| K992571 | I-STAT SYSTEM | I-Stat Corp. | 2000-02-10 | 192 | 4 |
| K992851 | ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FO | Roche Diagnostics Corp. | 2000-01-14 | 143 | 0 |
| K984141 | GBACT + KIT | Sienco, Inc. | 1999-05-28 | 191 | 0 |
| K983649 | MAX-ACT | Array Medical, Inc. | 1998-12-11 | 56 | 0 |
| K971935 | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOM | B & D Corp. | 1997-10-01 | 127 | 0 |
| K964609 | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME T | Array Medical, Inc. | 1997-03-06 | 108 | 0 |
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | International Technidyne Corp. | 1996-08-12 | 171 | 3 |
| K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | International Technidyne Corp. | 1994-06-30 | 121 | 0 |
| K923594 | CLOTTRAC COAGULATION CONTROL | Medtronic Hemotec, Inc. | 1992-09-21 | 63 | 0 |
| K913861 | HEMOCHRON(R) KACT | International Technidyne Corp. | 1991-10-18 | 52 | 0 |
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | Hemotec, Inc. | 1990-07-03 | 56 | 0 |
| K854686 | TE-25 COAGURO METER | Future Impex Corp. | 1986-06-04 | 196 | 0 |
| K860122 | HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME | Medical Device Consultants, Inc. | 1986-04-04 | 80 | 1 |
| K843459 | HEMOTEC ACT I SYSTEM | Hemotec, Inc. | 1984-12-12 | 98 | 0 |
| K832189 | HEMOCHRON THROMBOCHRONOMETER | International Technidyne Corp. | 1983-10-14 | 98 | 0 |
| K790346 | ACTIVATOR | Tri-Med, Inc. | 1979-03-21 | 28 | 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