510(k) · Cleared

Recalled · 2007

Remstar Plus Cpap System

K010263510(k) TraditionalCleared Mar 29, 200159-day reviewClass II21 CFR 868.5905Recalls 3

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 Mar 29, 2001 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 of the 142 devices in its family, counting itself, have a Class I recall. 141 later devices descend from it. It has been recalled 3 times.

Decided: Mar 29, 2001
Review: 59 days
Class: Class II
Product code: BZD
Recalls: 3
Predicates: 0

141 later devices descend from it, 8 citing it directly. 23 of the 142 devices in this family, counting this one, have a Class I recall.

This deviceK010263 Remstar Plus Cpap SystemRespironics, Inc. · 2001
Descendant · cites it directly · 92 of its ownK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
Descendant · 2 generations on · 74 of its ownK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
Descendant · cites it directly · 61 of its ownK020777 Bipap Synchrony Ventilatory Support System with BI-FlexRespironics, Inc. · 2002 · Recalled
Descendant · 2 generations on · 59 of its ownK070328 Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group · 2007
Descendant · 2 generations on · 47 of its ownK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · Recalled

Showing 5 of 141 descendants. See all descendants

Descendants cleared per year

2002high 14 (2012) · low 1 (2003)2026

Class I recalls in this family

K122769 Remstar SEcites it directly · 2012
K090248 Bipap Autosv2 generations on · 2009
K130077 Remstar SE2 generations on · 2013
K082660 V60 Ventilator, Model V80003 generations on · 2009

Most influential descendants

Showing 5 of 141 · See all

K012554Remstar Auto Cpap SystemRespironics, Inc. · 2002 · cites it directly92descendants
K031460Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003 · 2 generations on74descendants
K020777Bipap Synchrony Ventilatory Support System with BI-FlexRespironics, Inc. · 2002 · cites it directly61descendants
K070328Bipap Synchrony with AvapsRespironics Inc., Sleep & Home Respiratory Group · 2007 · 2 generations on59descendants
K021861Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · 2 generations on47descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010263	Remstar Plus Cpap System	Respironics, Inc.	2001	—
+1	K012554	Remstar Auto Cpap System	Respironics, Inc.	2002	—
+2	K031460	Modification to Remstar Auto Cpap System	Respironics, Inc.	2003	—
+1	K020777	Bipap Synchrony Ventilatory Support System with BI-Flex	Respironics, Inc.	2002	2
+2	K070328	Bipap Synchrony with Avaps	Respironics Inc., Sleep & Home Respiratory Group	2007	—
+2	K021861	Remstar Pro with C-Flex Cpap System	Respironics, Inc.	2002	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	1	0
2004	5	0
2005	7	0
2006	1	0
2007	3	0
2008	1	0
2009	9	4
2010	5	2
2011	8	5
2012	14	3
2013	14	3
2014	7	0
2015	5	0
2016	9	1
2017	4	1
2018	4	1
2019	5	2
2020	7	0
2021	3	1
2022	4	0
2023	2	0
2024	5	0
2025	8	0
2026	7	0

FIG. 1 — Lineage of K010263, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

23 devices in this family have a Class I recall. 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (141)

See all 141

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012554	Remstar Auto Cpap System	Respironics, Inc.	2002	92
K020777	Bipap Synchrony Ventilatory Support System with BI-Flex	Respironics, Inc.	2002	61
K042945	Aura Cpap System	Aeiomed, Inc.	2005	6
K091112	Respironics Sleepeasy Cpap System	Respironics, Inc.	2009	4
K122769	Remstar SE Class I	Respironics, Inc.	2012	3
K102625	Vega Cpap System/Heated Humidifier, Model CP-03	Vega Technologies, Inc.	2011	0
K050990	Remrest Heated Humidifier	Medical Industries America, Inc.	2005	0
K040202	Salter Labs Cpap High Flow Cannula System	Salter Labs	2005	0

Has anything in its family been recalled? (23 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 15, 2007	Not classified	Z-1066-2008	Environmental control	Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Oct 25, 2006	Not classified	Z-0447-2007	Other	AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device
Oct 25, 2006	Not classified	Z-0446-2007	Other	AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K122769Remstar SERespironics, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
K130077Remstar SERespironics, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 5 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls

Nearest 12 of 23 shown.

Nearest 5 of 23; all are on the web page.

What does this lineage say?

Of its descendants, K012554 (Respironics, Inc., 2002) has gone furthest, with 92 descendants of its own.

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)	—

https://510kreport.com/device/K010263 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010263: Remstar Plus Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010263

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026