510(k) · Cleared

Cleared

Bipap Duet System

K964363510(k) TraditionalCleared Jan 30, 199790-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jan 30, 1997 as substantially equivalent to K883825 (Respironics, Inc., 1988) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1988.

Decided: Jan 30, 1997
Review: 90 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K883825 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK883825 Modified Sanders BI-PapeasyRespironics, Inc. · 1988
This deviceK964363 Bipap Duet 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)	K964363	Bipap Duet System	Respironics, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K964363, 1988–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K883825	Modified Sanders BI-Papeasy Summary page 1 …irs Respironics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 21 CFR 868.5905, 73 BZD Ventilator, Noncontinuous BiPAP Duet System Respironics BiPAP S-D System (K883825 & K905540) © 1996 Respironics, Inc. October 30, 1996 . Section 12, Page 1 Premarket Notification Section 510(k)…	Respironics, Inc.	1988	—
*	K905540	Respironics Bipap Remote Control Unit Summary page 1 …onics, Inc. 1001 Murry Ridge Drive Murrysville, PA 15668 21 CFR 868.5905, 73 BZD Ventilator, Noncontinuous BiPAP Duet System Respironics BiPAP S-D System (K883825 & K905540) © 1996 Respironics, Inc. October 30, 1996 . Section 12, Page 1 Premarket Notification Section 510(k) BiPAP Due…	Respironics, Inc.	1991	—

Also cleared against K883825: 4 other devices →

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 2 ancestors has a recall.
4 other devices also cite its predicate K883825.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007high 90,768 (2022) · low 65 (2007)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 BiPAP Duet System delivers CPAP and bi-level positive airway pressure therapies for the treatment of adult OSA. The BiPAP Duet System is intended for use in the home and 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. When used in clinical settings, the BiPAP Duet System can be used with or without the Respironics Maestro Clinical Remote Control. The BiPAP Duet System 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/K964363 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964363: Bipap Duet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964363

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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