# K771346: CI-Trol Coagulation Controls II & Iii

- Pathway: 510(k) (Traditional)
- Applicant: Dade, Baxter Travenol Diagnostics, Inc.
- Decided: Aug 22, 1977 after 33 days
- Product code: GGN (Plasma, Coagulation Control)
- 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K992279: Heparin Control Plasma Level 2 (1999), 1 descendant of its own
- K992278: Heparin Control Plasma Level 1 (1999), 1 descendant of its own
- K984130: Coagulation Control Level 2 (Abnormal) (1998), 1 descendant of its own
- K984131: Coagulation Control Level 3 (Abnormal) (1998), 1 descendant of its own
- K060968: Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K771346
Methodology: https://510kreport.com/methodology