# K120642: Resuscitaire with Autobreath

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Nov 2, 2012 after 245 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892885 (1989). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003335: Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted Radiant Warmer, Hill-Rom Air-Shields (2000) Summary page 1.
- K896381: MVP-10 Mri Infant Ventilator, Bio-Med Devices, Inc. (1990) Summary page 2.
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator, Fisher & Paykel Electronics, Ltd. (1989) Summary page 1.

## Most influential descendants
- K230278: Babyroo TN300 (2023), 1 descendant of its own
- K243606: Babyroo TN300 (2025), 0 descendants of its own

## Recalls of this device
- May 16, 2023 · Class II · Z-1992-2023: The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

## Indications for use
The Resuscitaire® Radiant Warmer is intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10kg. It is not intended for long term resuscitation or home use.

Source page: https://510kreport.com/device/K120642
Methodology: https://510kreport.com/methodology