# K122705: Humicare D900

- Pathway: 510(k) (Traditional)
- Applicant: Grundler GmbH
- Decided: May 21, 2013 after 259 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: 7 generations back to K913368 (1992). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073706: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.
- K092256: Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012, Smiths Medical Asd, Inc. (2010) Summary page 1.
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 1.
- K100104: Hybernite Rainout Control System, Plastiflex Group NV (2010) Summary page 1.

## Most influential descendants
- K133766: Humicare D900 (2014), 0 descendants of its own

## Indications for use
The GrOndler's HumiCare 0900 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. Healed 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 GrOndlers HumiCare 0900. The heated breathing circuits are used for flow rates greater than 3t/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/K122705
Methodology: https://510kreport.com/methodology