# JPA: System, Multipurpose For In Vitro Coagulation Studies

- Device class: 2; regulation: 21 CFR 864.5425; FDA's rule: 510(k) required
- FDA decisions: 181
- 510(k) review time 2021–2025: median 266 days (middle half 31–518)
- Recalls: 27 (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)
- 2016: 6
- 2017: 4
- 2018: 1
- 2019: 3
- 2021: 1
- 2022: 1
- 2023: 3
- 2024: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K002400: Modification of Acl Advance (2000), cited by 14
- K011235: Sysmex Automated Coagulation Analyzer / Model # CA-1500 (2001), cited by 8
- K002177: Thrombelastograph Coagulation Analyzer Teg-5000 Series (2000), cited by 4
- K150041: CORA (Coagulation Resonance Analysis) System (2015), cited by 3
- K924453: Multi-Channel Discrete Analyzer (Mda-180) (1992), cited by 3
- K864271: IL Test 84673-30 Chromogenics Control Plasma (1986), cited by 3
- K952560: Sonoclot Coagulation & Platelet Function Analyzer (1995), cited by 3
- K926551: Behring Fibrintimer a (1995), cited by 3
- K050243: Immedia Prothrombin Time System (2005), cited by 2
- K101533: EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System (2011), cited by 2

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