# K870976: Onguard 1000, Catalog #043611-000 & 043611-001

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Laboratories, Inc.
- Decided: May 6, 1987 after 57 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K981412: M1145 (UPS1-1.25K-1G-MP) Ups (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K870976
Methodology: https://510kreport.com/methodology