# K071163: Weinmanncomfort 2, Model WM 27600 and Weinmannaqua, Model WM 27603

- Pathway: 510(k) (Traditional)
- Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
- Decided: Jul 18, 2007 after 83 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 K971260 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013909: S7 Elite CP AP System, Resmed Corp (2002) Summary page 1.

## Most influential descendants
- K072009: Weinmanncompact, Model WM 27380; WEINMANNCLICK2, Model WM 27340 (2007), 0 descendants of its own

## Indications for use
The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.

Source page: https://510kreport.com/device/K071163
Methodology: https://510kreport.com/methodology