# K093913: Mercury Medical T-Piece Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Mercury Medical, Inc.
- Decided: Apr 6, 2010 after 105 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K760102 (1976). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070210: Giraffe and Panda  T- Piece Resuscitation System, Ohmeda Medical (2007) Summary page 5.
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator, Fisher & Paykel Electronics, Ltd. (1989) Summary page 1.

## Most influential descendants
- K173373: SafeT T-Piece Resuscitator (2018), 0 descendants of its own

## Recalls of this device
- Dec 10, 2024 · Class I · Z-0821-2025: Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure range
- Aug 30, 2024 · Class I · Z-0004-2025: Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
- Oct 22, 2015 · Class II · Z-0639-2016: Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.

## Indications for use
The Neo-TeeTm 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 I10kg (22 lb).

Source page: https://510kreport.com/device/K093913
Methodology: https://510kreport.com/methodology