510(k) · Cleared

Recalled · Class I · 2021

Remstar Auto a-Flex

K091319510(k) TraditionalCleared Aug 3, 200990-day reviewClass II21 CFR 868.5905Recalls 1 (1 Class I)

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

Respironics Inc., Sleep & Home Respiratory Group · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Aug 3, 2009 as substantially equivalent to K063830 (Respironics Inc., Sleep & Home Respiratory Group, 2007) after a 90-day review. Its family tree reaches back 8 generations to 1996. 12 of the 52 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it. It has been recalled once, including a Class I recall.

Decided: Aug 3, 2009
Review: 90 days
Class: Class II
Product code: BZD
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 8 generations to K953930 (1996). 29 ancestors in all, the oldest K930656 (1994). 22 later devices descend from it, 2 citing it directly. 12 of the 52 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
7 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
6 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
5 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
4 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
3 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
2 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
1 generation backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
This deviceK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009
Descendant · cites it directly · 11 of its ownK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
Descendant · cites it directly · 9 of its ownK113068 Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Recalled (Class I)
Descendant · 2 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Descendant · 3 generations on · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Descendant · 4 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2010high 3 (2011) · low 0 (2014)2026

Class I recalls in this family

K092818 Bipap Avaps Ventilatory Support Systemcites it directly · 2010
K113068 Remstar Auto a-Flex HTcites it directly · 2011
K113053 Bipap a 30 Ventilatory Support System2 generations on · 2012
K102465 Bipap Avaps Ventilatory Support System2 generations on · 2011

Most influential descendants

Showing 5 of 22 · See all

K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · cites it directly11descendants
K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · cites it directly9descendants
K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on8descendants
K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on6descendants
K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K953930	Virtuoso Smart Cpap System	Respironics, Inc.	1996	—
−7	K993433	Virtuoso LX Smart Cpap System	Respironics, Inc.	1999	—
−6	K012554	Remstar Auto Cpap System	Respironics, Inc.	2002	—
−5	K031460	Modification to Remstar Auto Cpap System	Respironics, Inc.	2003	—
−4	K032834	Bipap Pro 2 BI-Level System	Respironics, Inc.	2004	—
−3	K043607	Bipap Pro 2 BI-Level System with BI-Flex	Respironics, Inc.	2005	—
−2	K050759	Bipap Auto	Respironics, Inc.	2005	1
−1	K063830	Remstar Aflex Cpap System	Respironics Inc., Sleep & Home Respiratory Group	2007	—
0 (this device)	K091319	Remstar Auto a-Flex	Respironics Inc., Sleep & Home Respiratory Group	2009	—
+1	K092818	Bipap Avaps Ventilatory Support System	Respironics, Inc.	2010	Class I
+1	K113068	Remstar Auto a-Flex HT	Respironics, Inc.	2011	Class I
+2	K113053	Bipap a 30 Ventilatory Support System	Respironics, Inc.	2012	Class I
+3	K121623	Bipap a 40 Ventilatory Support System	Respironics, Inc.	2012	Class I
+4	K181166	Trilogy Evo	Respironics, Inc.	2019	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0
1997	2	0
1998	2	0
2000	2	0
2001	3	0
2002	3	0
2003	3	0
2004	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	1
2011	3	3
2012	3	3
2013	2	2
2015	1	0
2019	1	1
2020	1	0
2021	2	1
2022	2	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K091319, 1996–2026Source: 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.

12 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K063830	Remstar Aflex Cpap System Summary page 1 …Q Series Auto with AFLEX CPAP System Predicate Device(s) Respironics REMstar M Series Auto with AFLEX CPAP System (K063830) Reason for submission Modified design. ©2009 Respironics Inc. 5/4/2009…	Respironics Inc., Sleep & Home Respiratory Group	2007	—

Also cleared against K063830: 2 other devices →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K092818	Bipap Avaps Ventilatory Support System Class I	Respironics, Inc.	2010	11
K113068	Remstar Auto a-Flex HT Class I	Respironics, Inc.	2011	9

Has anything in its family been recalled? (12 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 14, 2021	Class I	Z-1974-2021	Device Design	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

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.

K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K113068Remstar Auto a-Flex HTRespironics, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K131982Remstar Auto a-Flex HTRespironics, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
K122769Remstar SERespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
K130077Remstar SERespironics, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

Nearest 5 of 11; all are on the web page.

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
9 of the 29 ancestors have a recall of any class.
Of its descendants, K092818 (Respironics, Inc., 2010) has gone furthest, with 11 descendants of its own.
2 other devices also cite its predicate K063830.

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. 2009, this device’s year, is highlighted.

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 Respironics Q Series Auto with AFLEX CPAP System delivers positive airway

pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously

breathing patients weighing over 30kg (66 lbs). It is for use in the home or

hospital/institutional environment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091319 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091319: Remstar Auto a-Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091319

Report an extraction error

Are you the manufacturer?

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