# K961364: Automatic Tubing Clamp System (Atc)

- Pathway: 510(k) (Traditional)
- Applicant: Rocky Mountain Research, Inc.
- Decided: Oct 31, 1996 after 205 days
- Product code: KRL (Detector, Bubble, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4205
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K070286: Bio-Console, Model 560 (2007), 6 descendants of its own
- K080824: Bio-Console 560 (2008), 3 descendants of its own
- K131964: Bio-Console 560 Extracorporeal Blood Pumping Console (2013), 2 descendants of its own
- K221491: Anivia SG1000 Pump Console (2023), 1 descendant of its own
- K070213: Performer CBP System (2007), 1 descendant of its own

Source page: https://510kreport.com/device/K961364
Methodology: https://510kreport.com/methodology