510(k) · Cleared

Cleared

Respironics Bipap Remote Control Unit

K905540510(k) TraditionalCleared Jan 30, 199150-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, 1991 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 of the 48 devices in its family, counting itself, have a Class I recall. 47 later devices descend from it.

Decided: Jan 30, 1991
Review: 50 days
Class: Class II
Product code: BZD
Recalls: None
Predicates: 0

47 later devices descend from it, 3 citing it directly. 9 of the 48 devices in this family, counting this one, have a Class I recall.

This deviceK905540 Respironics Bipap Remote Control UnitRespironics, Inc. · 1991
Descendant · cites it directly · 44 of its ownK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
Descendant · 2 generations on · 42 of its ownK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
Descendant · 3 generations on · 14 of its ownK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)
Descendant · 3 generations on · 11 of its ownK053168 Bipap FocusRespironics (Ireland) Limited · 2006 · Recalled
Descendant · 4 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

1996high 5 (2012) · low 0 (1999)2026

Class I recalls in this family

K023350 Esprit Ventilator with Respiratory Mechanics3 generations on · 2002
K072885 Carina System, Model 8419350; Carina Basic…3 generations on · 2008
K082660 V60 Ventilator, Model V80003 generations on · 2009
K034040 Esprit Ventilator, Model V10004 generations on · 2004

Most influential descendants

Showing 5 of 47 · See all

K955324Bipap S/T-D 30 SystemRespironics, Inc. · 1996 · cites it directly44descendants
K982454Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · 2 generations on42descendants
K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 3 generations on14descendants
K053168Bipap FocusRespironics (Ireland) Limited · 2006 · 3 generations on11descendants
K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 4 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K905540	Respironics Bipap Remote Control Unit	Respironics, Inc.	1991	—
+1	K955324	Bipap S/T-D 30 System	Respironics, Inc.	1996	—
+2	K982454	Bipap Vision Ventilatory Support	Respironics, Inc.	1998	2
+3	K082660	V60 Ventilator, Model V8000	Respironics California, Inc.	2009	Class I
+3	K053168	Bipap Focus	Respironics (Ireland) Limited	2006	1
+4	K071560	Provent Nasal Dilator, Model BR2	Ventus Medical, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	2	0
1998	2	0
2002	1	1
2004	3	1
2006	1	0
2007	1	0
2008	2	1
2009	3	1
2010	2	0
2011	1	1
2012	5	2
2013	1	0
2014	1	0
2015	1	0
2018	1	0
2019	1	1
2020	2	0
2021	1	1
2022	2	0
2023	3	0
2024	4	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K905540, 1991–2026Source: 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.

9 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?

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

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K955324	Bipap S/T-D 30 System	Respironics, Inc.	1996	44
K963761	Quartet Clinical System	Respironics, Inc.	1997	0
K964363	Bipap Duet System	Respironics, Inc.	1997	0

Has anything in its family been recalled? (9 Class I)

No FDA recall names this 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.

K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · 3 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 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
K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 4 generations on · ◆ in the 2004 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
K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
K193586Vivo 45 LSBreas Medical AB · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

Nearest 5 of 9; all are on the web page.

What does this lineage say?

Of its descendants, K955324 (Respironics, Inc., 1996) has gone furthest, with 44 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/K905540 · printed Nov 3, 2026

Cite this page

510(k) Report. “K905540: Respironics Bipap Remote Control Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905540

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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