# K971198: Babytherm 8004 Babytherm 8010

- Pathway: 510(k) (Traditional)
- Applicant: Drager, Inc.
- Decided: Oct 3, 1997 after 186 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 K912908 (1991). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945467: Babytherm 8000 WB, Drager, Inc. (1995) Summary page 2.
- K953489: Drager Infant Radiant Warmern RH600, Drager, Inc. (1996) Summary page 2.
- K954611: Drager PT4000 Phototherapy System, Drager, Inc. (1995) Summary page 2.
- K912908: Air-Shields Micro-Lite Phototherapy System, Air-Shields Vickers, Inc. (1991) Summary page 2.

## Most influential descendants
- K993051: Versalet 7700 Care Center, Model # 7700 (2000), 1 descendant of its own
- K053399: Versalet 7700 Care Center (2006), 0 descendants of its own

## Recalls of this device
- Jun 22, 2016 · Class II · Z-2295-2016: Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.

## Indications for use
Babytherm 8004 / 8010 is an infant warmer system intended as a therapeutic device providing warmth for premature and full-term neonates and infants with a weight up to 16 Ibs. It is intended for use in delivery rooms, operating theatres, maternity and obstetric units, neonatal wards, neonatal and paediatric intensive care units. Both Systems can be equipped with the optional phototherapy system for treatment of Hyperbilirubinemia.

Source page: https://510kreport.com/device/K971198
Methodology: https://510kreport.com/methodology