# K221491: Anivia SG1000 Pump Console

- Pathway: 510(k) (Traditional)
- Applicant: Apmtd, Inc.
- Decided: Feb 3, 2023 after 256 days
- Product code: DWA (Control, Pump Speed, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915183 (1992). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131964: Bio-Console 560 Extracorporeal Blood Pumping Console, Medtronic, Inc. (2013) Summary page 4.

## Most influential descendants
- K230698: Anivia SG1000 Pump Console (2023), 0 descendants of its own

## Indications for use
The Anivia SG1000 Pump Console is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass (up to 6 hours). Contraindications: The Anivia SG1000 Pump Console is contraindicated as a cardiotomy suction device. It is the responsibility of the physician to determine whether any physical impairment of the patient or associated equipment would contraindicate the use of this device.

Source page: https://510kreport.com/device/K221491
Methodology: https://510kreport.com/methodology