# K173373: SafeT T-Piece Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Ventlab, LLC
- Decided: Nov 16, 2018 after 385 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: 4 generations back to K760102 (1976). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093913: Mercury Medical T-Piece Resuscitator, Mercury Medical, Inc. (2010) Summary page 4.

## Indications for use
The SafeT T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10 kg (22 lb).

Source page: https://510kreport.com/device/K173373
Methodology: https://510kreport.com/methodology