# K060461: V-505 Infa Warmer

- Pathway: 510(k) (Special)
- Applicant: Atom Medical, Inc.
- Decided: Apr 28, 2006 after 65 days
- Product code: FMT (Warmer, Infant Radiant)
- Device class: 2
- Regulation: 21 CFR 880.5130
- 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 K940951 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940951: RW Resucitaire Infant Radiant Warmer, Air-Shields, Inc. (1995) Summary page 1.
- K002355: Atom Infa Warmer V-505, Atom Medical Corp (2000) Summary page 1.

## Most influential descendants
- K103317: Resuscitation Unit 105 (2011), 0 descendants of its own
- K102227: Infa Warmer I (2011), 0 descendants of its own

## Indications for use
The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery. This device is not intended for home use.

Source page: https://510kreport.com/device/K060461
Methodology: https://510kreport.com/methodology