# Draeger Medical Sytems, Inc.

- Location (FDA's records): Andover, MA
- FDA decisions: 2 (2015–2018): 2 510(k) clearances
- Product codes: MHX (1), FMZ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Draeger Medical Systems, Inc.: 1 (https://510kreport.com/company/draeger-medical-systems)
- Hill-Rom Air-Shields: 1 (https://510kreport.com/company/hill-rom-air-shields)

## Firms that cite its devices most
- Draeger Medical Systems, Inc.: 1 (https://510kreport.com/company/draeger-medical-systems)
- Mom Incubators Limited: 1 (https://510kreport.com/company/mom-incubators)

## Its most-cited devices
- K172154: Isolette 8000 plus (2018), cited by 2

## Recent decisions
- K172154: Isolette 8000 plus (Apr 19, 2018)
- K152407: Infinity Delta, Infinity Delta XL, Infinity Kappa (Sep 23, 2015)

Source page: https://510kreport.com/company/draeger-medical-sytems