# K073410: Save Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Artivent Corporation
- Decided: Sep 12, 2008 after 283 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- 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 K023793 (2003). 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)
- K023793: 1ST Response Intermediate Manual Resuscitator, Portex, Inc. (2003) Summary page 1.
- K053140: Ambu Mark IV Resuscitator, Ambu A/S (2005) Summary page 1.

## Indications for use
The SAVeTM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. SAVe TM Resuscitator is intended for patients with a body mass of more than 15kg (~33 lbs), approx. 3 years of age.

Source page: https://510kreport.com/device/K073410
Methodology: https://510kreport.com/methodology