Atlas FDA

JBP

24 FDA 510(k) clearances · Product code

106 daysmedian time to decision
192 days90th percentile
24clearances measured

FDA profile

Official device name
Activated Whole Blood Clotting Time
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7140
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 16 · 2019: 15 · 2023: 16 · 2024: 23 · 2025: 18 · 2026: 34
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (K223635)Sienco, Inc.2023-01-04
RAPIDTEG TEG-ACT TEST (K062604)Haemoscope Corp.2007-01-31
AIACT KIT (K032952)Sienco, Inc.2003-12-12
I-STAT KAOLIN ACT TEST (K023582)I-Stat Corporation2003-09-08
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (K020914)Helena Laboratories2002-05-23
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (K013078)Helena Laboratories2002-01-10
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION (K002528)Sienco, Inc.2000-08-31
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (K994194)Cardiovascular Diagnostics, Inc.2000-03-28
I-STAT SYSTEM (K992571)I-Stat Corp.2000-02-10
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM (K992851)Roche Diagnostics Corp.2000-01-14
GBACT + KIT (K984141)Sienco, Inc.1999-05-28
MAX-ACT (K983649)Array Medical, Inc.1998-12-11
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) (K971935)B & D Corp.1997-10-01
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE (K964609)Array Medical, Inc.1997-03-06
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT (K960749)International Technidyne Corp.1996-08-12
CATALOG NO. J-ACT+ & QC-ACT+ (K941007)International Technidyne Corp.1994-06-30
CLOTTRAC COAGULATION CONTROL (K923594)Medtronic Hemotec, Inc.1992-09-21
HEMOCHRON(R) KACT (K913861)International Technidyne Corp.1991-10-18
CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL (K902081)Hemotec, Inc.1990-07-03
TE-25 COAGURO METER (K854686)Future Impex Corp.1986-06-04
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME (K860122)Medical Device Consultants, Inc.1986-04-04
HEMOTEC ACT I SYSTEM (K843459)Hemotec, Inc.1984-12-12
HEMOCHRON THROMBOCHRONOMETER (K832189)International Technidyne Corp.1983-10-14
ACTIVATOR (K790346)Tri-Med, Inc.1979-03-21

Track JBP automatically

Every clearance here is in the API, with alerts when new ones post.