# K984501: Dade Behring Bftii

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 28, 1999 after 222 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926551 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955278: Behring Coagulation Timer, Behring Diagnostics, Inc. (1996) Summary page 1.
- K964139: Sysmex CA-6000, Dade Intl., Inc. (1997) Summary page 1.

## Indications for use
The Dade Behring BFTll is a semi-automated device intended for use to determine PT, aPTT, and Fibrinogen.

Source page: https://510kreport.com/device/K984501
Methodology: https://510kreport.com/methodology