# K192177: SysMed S/T

- Pathway: 510(k) (Traditional)
- Applicant: Sysmed (China) Co., Ltd.
- Decided: Nov 25, 2020 after 471 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: 10 generations back to K971260 (1997). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140159: S9 Wanda Vpap ST, Resmed, Ltd. (2014) Summary page 6.

## Indications for use
The device provides positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome in self breathing patients weighing over 30kg (66lbs). This product can be used in the home as well as in clinical/hospital environments.

Source page: https://510kreport.com/device/K192177
Methodology: https://510kreport.com/methodology