# K980886: Babytherm 8000 LDR

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical, Inc.
- Decided: May 29, 1998 after 81 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K94567: Babytherm 8000 WB. Number could not be read Summary page 1.

## Indications for use
The Babytherm 8000 LDR is indicated as a therapeutic device for providing warmth with or without the use of a canopy for premature and full-term neonates and infants up to 16 Ibs.

Source page: https://510kreport.com/device/K980886
Methodology: https://510kreport.com/methodology