510(k) · Cleared

Recalled · 2007

Bipap Pro BI-Level System

K011714510(k) SpecialCleared Jun 28, 200124-day reviewClass II21 CFR 868.5905Recalls 1

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 Jun 28, 2001 as substantially equivalent to K000994 (Respironics, Inc., 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000. 24 of the 105 devices in its family, counting itself, have a Class I recall. 103 later devices descend from it. It has been recalled once.

Decided: Jun 28, 2001
Review: 24 days
Class: Class II
Product code: BZD
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K000994 (2000). 103 later devices descend from it, 4 citing it directly. 24 of the 105 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK000994 Bipap Duet LX BI-Level SystemRespironics, Inc. · 2000 · Recalled
This deviceK011714 Bipap Pro BI-Level SystemRespironics, Inc. · 2001
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 · cites it directly · 52 of its ownK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
Descendant · cites it directly · 47 of its ownK021861 Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · Recalled
Descendant · 2 generations on · 42 of its ownK052110 M-Series Pro Cpap SytemRespironics, Inc. · 2005 · Recalled

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2002high 13 (2012) · low 1 (2003)2026

Class I recalls in this family

K090248 Bipap Autosv2 generations on · 2009
K090539 Bipap Autosv Advanced3 generations on · 2009
K082660 V60 Ventilator, Model V80003 generations on · 2009
K083526 Trilogy 100 Ventilator3 generations on · 2009

Most influential descendants

Showing 5 of 103 · See all

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
K031656Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003 · cites it directly52descendants
K021861Remstar Pro with C-Flex Cpap SystemRespironics, Inc. · 2002 · cites it directly47descendants
K052110M-Series Pro Cpap SytemRespironics, Inc. · 2005 · 2 generations on42descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000994	Bipap Duet LX BI-Level System	Respironics, Inc.	2000	1
0 (this device)	K011714	Bipap Pro BI-Level System	Respironics, Inc.	2001	—
+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	—
+1	K031656	Bipap Harmony Ventilatory Support System	Respironics, Inc.	2003	—
+1	K021861	Remstar Pro with C-Flex Cpap System	Respironics, Inc.	2002	1
+2	K052110	M-Series Pro Cpap Sytem	Respironics, Inc.	2005	15

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	1	0
2004	3	0
2005	3	0
2006	2	0
2007	6	0
2008	1	0
2009	10	5
2010	5	2
2011	8	5
2012	13	3
2013	8	3
2014	5	0
2015	2	0
2016	6	1
2017	2	1
2018	2	1
2019	3	2
2020	3	0
2021	2	1
2022	3	0
2023	2	0
2024	4	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K011714, 2000–2026Source: 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.

24 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
*	K000994	Bipap Duet LX BI-Level System Summary page 1 …urrysville, PA 15668 21 CFR 868.5905 BZD — Non-Continuous ventilator CPAP System Respironics BiPAP® Pro Bi-level System Respironics BiPAP® Duet® LX Bi-level System (K000994) Modified design, enhanced mode ©2001 Respironics Inc. 05/23/01 Summary, Page 1 of 2 Respironics BiPAP® Pro Bi…	Respironics, Inc.	2000	1

What descends from it? (103)

See all 103

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

Number	Device	Applicant	Decided	Descendants
K020777	Bipap Synchrony Ventilatory Support System with BI-Flex	Respironics, Inc.	2002	61
K031656	Bipap Harmony Ventilatory Support System	Respironics, Inc.	2003	52
K021861	Remstar Pro with C-Flex Cpap System	Respironics, Inc.	2002	47
K032834	Bipap Pro 2 BI-Level System	Respironics, Inc.	2004	40

Has anything in its family been recalled? (24 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 15, 2007	Not classified	Z-1076-2008	Environmental control	Foreign material: Glass fragments may present in the plastic bag material used to ship components.

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.

K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
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
K122769Remstar SERespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
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
K130077Remstar SERespironics, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

Nearest 12 of 24 shown.

Nearest 5 of 24; all are on the web page.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K020777 (Respironics, Inc., 2002) has gone furthest, with 61 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)	—

What is it indicated for?

The Respironics BiPAP® Pro Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only.

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/K011714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011714: Bipap Pro BI-Level System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011714

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026