# KFF: Assay, Heparin

- Device class: 2; regulation: 21 CFR 864.7525; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 341 days (middle half 341–341)
- Recalls: 4 (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)
- 1997: 2
- 1998: 2
- 2001: 2
- 2002: 3
- 2006: 1
- 2009: 1
- 2011: 1
- 2017: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K925433: The Stachrom Heparin Assay Kit (1995), cited by 2
- K854762: Hepanorm Calibration Plasma Set (1986), cited by 2
- K980242: IL Test Heparin (1998), cited by 2
- K090209: Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls (2009), cited by 2
- K213464: HemosIL Liquid Anti-Xa (2022), cited by 2
- K943520: Heparin Control Kit (1995), cited by 2
- K812424: CI-Trol Heparin Controls, Low/High (1981), cited by 1
- K983178: Coamatic Heparin (1998), cited by 1
- K843202: Heparin Calibrator Aca (1984), cited by 1
- K935212: IL Test Heparin (XA), PN 84699-15 (1994), cited by 1

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