# K133766: Humicare D900

- Pathway: 510(k) (Traditional)
- Applicant: Gruendler GmbH
- Decided: Nov 24, 2014 after 348 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913368 (1992). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122705: Humicare D900, Grundler GmbH (2013) Summary page 4.

## Indications for use
The Gründler’s HumiCare D900 system is intended to heat and humidify medical respiratory gases for patients. The device is for use during artificial ventilation or ventilatory support (e.g. invasive ventilation via tracheal tube or cannula), non-invasive ventilation, or respiratory therapy by means of a mask or other patient interface. Heated breathing circuits are intended to provide warmed and/or humidified breathing gases before entering the patient airway reducing or eliminating water. They are accessories for the Gründler’s HumiCare D900. The heated breathing circuits are used for flow rates greater than 3L/min. The system is for use in hospital/institutional environment or in the home environment by medically trained healthcare users.

Source page: https://510kreport.com/device/K133766
Methodology: https://510kreport.com/methodology