# K131877: Save II, Save II Basic

- Pathway: 510(k) (Traditional)
- Applicant: Automedx, Inc.
- Decided: Mar 21, 2014 after 269 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: 2 generations back to K931473 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
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.
- K071221: Save-Simplified Automated Ventilator, Models: 550X10, 600X10 and 600X12, Automedx, Inc. (2007) Summary page 1.

## Indications for use
The SAVe II series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe II series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments.

Source page: https://510kreport.com/device/K131877
Methodology: https://510kreport.com/methodology