510(k) · Cleared
ClearedQuartet Clinical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Apr 18, 1997 as substantially equivalent to K883825 (Respironics, Inc., 1988) and 2 other predicates after a 212-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Apr 18, 1997
- Review
- 212 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K883825 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK883825 Modified Sanders BI-PapeasyRespironics, Inc. · 1988
- This deviceK963761 Quartet Clinical SystemRespironics, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883825 | Modified Sanders BI-Papeasy | Respironics, Inc. | 1988 | — |
| 0 (this device) | K963761 | Quartet Clinical System | Respironics, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K883825 | Modified Sanders BI-PapeasySummary page 1…tion Name Noncontinuous Ventilator Common/Usual Name CPAP System Proprietary Name Respironics Quartet Clinical System Predicate Device(s) Respironics BiPAP S-D System (K883825 & K905540), Innovative Medical Systems DPAP System (K933184). The technological characteristics of the Quartet Clinical System… | 1988 |
| * | K905540 | Respironics Bipap Remote Control UnitSummary page 1…Noncontinuous Ventilator Common/Usual Name CPAP System Proprietary Name Respironics Quartet Clinical System Predicate Device(s) Respironics BiPAP S-D System (K883825 & K905540), Innovative Medical Systems DPAP System (K933184). The technological characteristics of the Quartet Clinical System are equiva… | 1991 |
| * | K933184 | Positive Airway Pressure SystemSummary page 1…tem Proprietary Name Respironics Quartet Clinical System Predicate Device(s) Respironics BiPAP S-D System (K883825 & K905540), Innovative Medical Systems DPAP System (K933184). The technological characteristics of the Quartet Clinical System are equivalent to the predicate devices as listed above in te… | 1994 |
| † | K953930 | Virtuoso Smart Cpap System | 1996 |
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?
- None of the 3 ancestors has a recall.
- 4 other devices also cite its predicate K883825.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Quartet Clinical System delivers continuous positive airway pressure (CPAP) and bi-level positive airway pressure therapies for the treatment of adult OSA. The Quartet Clinical System is intended for use by a qualified clinician (any individual trained to perform sleep study diagnoses) in clinical (hospital or sleep laboratory) settings where adult patients suffering from OSA are diagnosed and treated. The device is used in conjunction with masks, headgear, and various combinations of patient circuit accessories.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963761 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963761: Quartet Clinical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963761
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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