Atlas FDA

JOX

15 FDA 510(k) clearances · Product code

60 daysmedian time to decision
118 days90th percentile
15clearances measured

FDA profile

Official device name
Analyzer, Heparin, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5680
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
2022: 29 · 2023: 50 · 2024: 30 · 2025: 69 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (K111339)Medtronic, Inc.2011-06-08
HEPARIN DOSE RESPONSE CARTRIDGE (K102953)Medtronic, Inc.2010-11-04
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (K101271)Medtronic, Inc.2010-10-13
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K051040)Medtronic Perfusion Systems2005-05-24
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K043080)Medtronic Vascular2004-12-03
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (K042070)Medtronic Vascular2004-10-01
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST (K993519)Cardiovascular Diagnostics, Inc.2000-01-14
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (K922031)Medtronic Hemotec, Inc.1992-07-21
HEPCON HMS WITH BODY SURFACE AREA CALCULATION (K911240)Hemotech, Inc.1991-07-17
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. (K894317)Hemotec, Inc.1989-09-05
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (K854377)Hemotec, Inc.1985-12-04
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM (K841021)Hemotec, Inc.1984-05-25
HEPCOL SYSTEM B-10 & B-10-P (K830665)Hemotec, Inc.1983-06-08
HEPAQUANT (K813011)Streck Laboratories, Inc.1982-01-26
HEPCON/SYSTEM RC-10 (K800161)Hemotec, Inc.1980-03-19

Track JOX automatically

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