# K022934: Silentflow 2 Exhalation System, Model WM 23650

- Pathway: 510(k) (Traditional)
- Applicant: Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
- Decided: Nov 14, 2002 after 71 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: 1 generation back to K962203 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962203: Whisper Swivel II Exhalation Port, Respironics, Inc. (1996)
- K993094: Aero-Click, Map Medizintechnik Fur Arzt Und Patient GmbH (2000) Summary page 1.

## Indications for use
The Weinmann Silentflow 2 Exhalation System is intended for prescription use to be used with nasal masks which are used in CPAP or bi-level pressure therapy for adult patients (> 30 kg) and do not have a built-in exhalation device.

Source page: https://510kreport.com/device/K022934
Methodology: https://510kreport.com/methodology