# K142096: T-Piece Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Mercury Medical
- Decided: Oct 17, 2014 after 77 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: 5 generations back to K862830 (1986). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092085: Ispira Resuscitation Unit, Neoforce Group, Inc. (2009) Summary page 4.

## Indications for use
The 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 patients weighing greater than 10kg (>22lb). Environment of Use – Hospital, sub-acute facilities, and pre-hospital (EMS)

Source page: https://510kreport.com/device/K142096
Methodology: https://510kreport.com/methodology