# K182977: Isolette 8000 Plus

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Nov 21, 2018 after 26 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
Longest line of descent: 2 generations back to K001242 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172154: Isolette 8000 plus, Draeger Medical Sytems, Inc. (2018) Summary page 4.

## Indications for use
The Isolette® 8000 plus is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs). The Isolette® 8000 plus is not intended for home use.

Source page: https://510kreport.com/device/K182977
Methodology: https://510kreport.com/methodology