510(k) · Cleared
ClearedSysMed S/T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmed (China) Co., Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Nov 25, 2020 as substantially equivalent to K140159 (Resmed, Ltd., 2014) after a 471-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Nov 25, 2020
- Review
- 471 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K971260 (1997). 29 ancestors in all, the oldest K915460 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations between
- 3 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 2 generations backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- 1 generation backK140159 S9 Wanda Vpap STResmed, Ltd. · 2014
- This deviceK192177 SysMed S/TSysmed (China) Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 9 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 8 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 7 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 5 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 4 generations backK080131 Vpap STResmed, Ltd. · 2008
- 3 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 2 generations backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- 1 generation backK140159 S9 Wanda Vpap STResmed, Ltd. · 2014
- This deviceK192177 SysMed S/TSysmed (China) Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −9 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −8 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −7 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −5 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −4 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −3 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| −2 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| −1 | K140159 | S9 Wanda Vpap ST | Resmed, Ltd. | 2014 | — |
| 0 (this device) | K192177 | SysMed S/T | Sysmed (China) Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140159 | S9 Wanda Vpap STSummary page 6…o be sterilized by the user prior to use. The proposed device can be reused by single patient. 5. Identification of Predicate Device 510(k) Number: K140159 Product Name: S9 WANDA VPAP ST 6. Identification of Reference Device 510(k) Number: K153061 Product… | 2014 |
| † | K153061 | Juno VPAP ST-A | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 29 ancestors have a recall of any class.
- 1 other device also cites its predicate K140159.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192177: SysMed S/T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192177
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026