# K172154: Isolette 8000 plus

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Sytems, Inc.
- Decided: Apr 19, 2018 after 276 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: 1 generation back to K001242 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001242: Isolette Infant Incubator, Model C2HS, Hill-Rom Air-Shields (2000) Summary page 4.

## Most influential descendants
- K243437: mOm Essential Incubator (ME1) (2025), 0 descendants of its own
- K182977: Isolette 8000 Plus (2018), 0 descendants of its own

## Indications for use
The Isolette® 8000 plus incubator 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/K172154
Methodology: https://510kreport.com/methodology