# JBP: Activated Whole Blood Clotting Time

- Device class: 2; regulation: 21 CFR 864.7140; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 30 days (middle half 30–30)
- Recalls: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1994: 1
- 1996: 1
- 1997: 2
- 1998: 1
- 1999: 1
- 2000: 4
- 2002: 2
- 2003: 2
- 2007: 1
- 2023: 1

## Most-cited predicates
- K960749: Hemochron JR. Microcoagulation Low Range Act (1996), cited by 3
- K941007: Catalog NO. J-Act+ & QC-Act+ (1994), cited by 2
- K913861: Hemochron (R) Kact (1991), cited by 2
- K002528: Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer Option (2000), cited by 1
- K832189: Hemochron Thrombochronometer (1983), cited by 1
- K902081: Clottrac (TM) Ibex Heparinase HR Act Cart./Control (1990), cited by 1
- K964609: Actalyke Activated Clotting Time Test System/Clotting Time Tubes/Whole Blood QC Kit/Actalyke Electronic Clotting Tube (1997), cited by 1

Source page: https://510kreport.com/product-code/JBP
Data by year (CSV): https://510kreport.com/product-code/JBP.csv