# K071221: Save-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12

- Pathway: 510(k) (Traditional)
- Applicant: Automedx, Inc.
- Decided: Sep 6, 2007 after 127 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931473 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931473: Impact Model 753, Impact Instrumentation, Inc. (1994) Summary page 1.

## Most influential descendants
- K131877: Save II, Save II Basic (2014), 0 descendants of its own

## Indications for use
The SAVe is intended for use on adults that need ventilatory support. Specifically, the SAVe is intended to provide short term ventilatory support for individuals during CPR or when positive-pressure ventilation is required to manage acute respiratory failure. The SAVe device is appropriate for individuals that weigh at least 45 kilograms. It is intended to be used in field hospitals, transport and pre-hospital environments.

Source page: https://510kreport.com/device/K071221
Methodology: https://510kreport.com/methodology