510(k) · Cleared

Cleared

Bipap Model S/T-D

K951264510(k) TraditionalCleared Jul 29, 1996496-day reviewClass II21 CFR 868.5895

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

Respironics, Inc. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator

Cleared on Jul 29, 1996 as substantially equivalent to K883825 (Respironics, Inc., 1988) and 1 other predicate after a 496-day review. Its family tree reaches back 1 generation to 1983. 14 of the 88 devices in its family, counting itself, have a Class I recall. 85 later devices descend from it.

Decided: Jul 29, 1996
Review: 496 days
Class: Class II
Product code: MNT
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K833786 (1983). 2 ancestors in all. 85 later devices descend from it, 3 citing it directly. 14 of the 88 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
This deviceK951264 Bipap Model S/T-DRespironics, Inc. · 1996
Descendant · cites it directly · 58 of its ownK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
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 · 2 generations on · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
Descendant · 3 generations on · 14 of its ownK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

1996high 10 (2011) · low 0 (1997)2026

Class I recalls in this family

K063268 Cpap/Vpap Masks, Models 1225, 1205 and 12352 generations on · 2007
K092818 Bipap Avaps Ventilatory Support System3 generations on · 2010
K023350 Esprit Ventilator with Respiratory Mechanics3 generations on · 2002
K072885 Carina System, Model 8419350; Carina Basic…3 generations on · 2008

Most influential descendants

Showing 5 of 85 · See all

K991648Reusable Contour II Nasal MaskRespironics, Inc. · 1999 · cites it directly58descendants
K955324Bipap S/T-D 30 SystemRespironics, Inc. · 1996 · cites it directly44descendants
K982454Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · 2 generations on42descendants
K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 2 generations on28descendants
K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K833786	Microprocessor Ventilator 7200	Puritan Bennett Corp.	1983	—
0 (this device)	K951264	Bipap Model S/T-D	Respironics, Inc.	1996	—
+1	K991648	Reusable Contour II Nasal Mask	Respironics, Inc.	1999	—
+1	K955324	Bipap S/T-D 30 System	Respironics, Inc.	1996	—
+2	K982454	Bipap Vision Ventilatory Support	Respironics, Inc.	1998	2
+2	K071509	Bipap Synchrony 2 Ventilatory Support System	Respironics Inc., Sleep & Home Respiratory Group	2007	2
+3	K082660	V60 Ventilator, Model V8000	Respironics California, Inc.	2009	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	2	0
1999	2	0
2002	2	1
2004	3	1
2005	1	0
2006	2	0
2007	4	1
2008	3	1
2009	6	1
2010	5	1
2011	10	3
2012	8	2
2013	2	0
2014	2	0
2015	4	1
2017	1	0
2018	1	0
2019	2	1
2020	3	0
2021	3	1
2022	2	0
2023	3	0
2024	5	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K951264, 1983–2026Source: 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.

14 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 MNT device

#1 K233643 F&P Airvo 3 NIV (PT311US)score 13.5 · 10 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? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K883825	Modified Sanders BI-Papeasy Summary page 1 …latory Affairs Device Name: BiPAP® S/T-D Common Name: Continuous Ventilator, Passive Exhalation Port, Critical Care Classification: 868.5895 Predicate Device: BiPAP® (K883825) Detachable Control Panel (KS05540) Siemens Servo 900 (K81102) Puritan Bennett 7200 (K823958/B and K833786) Page 1 === Page 2…	Respironics, Inc.	1988	—
Kept off the family tree	K950540	FDA’s K950540 is Implantable Clip Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	United States Surgical, A Division of Tyco Healthc	1995	—
Kept off the family tree	K810102	FDA’s K810102 is Infant Ecg Electrode #60-1029 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Aspen Laboratories, Inc.	1981	—
Kept off the family tree	K823958	Puritan Bennett 7200 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1 …on Port, Critical Care Classification: 868.5895 Predicate Device: BiPAP® (K883825) Detachable Control Panel (KS05540) Siemens Servo 900 (K81102) Puritan Bennett 7200 (K823958/B and K833786) Page 1 Premarket Notification, Part A BiPAP S/T-D System Section 16, 510(k) Summary Description…
*	K833786	Microprocessor Ventilator 7200 Summary page 1 …cal Care Classification: 868.5895 Predicate Device: BiPAP® (K883825) Detachable Control Panel (KS05540) Siemens Servo 900 (K81102) Puritan Bennett 7200 (K823958/B and K833786) Page 1 Premarket Notification, Part A BiPAP S/T-D System Section 16, 510(k) Summary Description of the BiPAP S…	Puritan Bennett Corp.	1983	—

Also cleared against K883825: 4 other devices →

What descends from it? (85)

See all 85

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

Number	Device	Applicant	Decided	Descendants
K991648	Reusable Contour II Nasal Mask	Respironics, Inc.	1999	58
K955324	Bipap S/T-D 30 System	Respironics, Inc.	1996	44
K990574	Stick-on Disposable Nasal Mask, Model 312174, 1001964	Respironics, Inc.	1999	0

Has anything in its family been recalled? (14 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.

K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
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
K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 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
K140980TI Nasal MaskRespironics, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall

Nearest 12 of 14 shown.

Nearest 5 of 14; all are on the web page.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K991648 (Respironics, Inc., 1999) has gone furthest, with 58 descendants of its own.
4 other devices also cite its predicate K883825.

How does its category compare?

All MNT devices

MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNT

1in 2025

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNT

Too few MNT 510(k)s in any year since 2007 to give a median.

Recalls per year · MNT

5in 2022

2007high 33 (2020) · low 0 (2008)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · MNT

3,545in 2025

2007high 9,350 (2019) · low 29 (2009)2025

MAUDE reports naming product code MNT, 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	0	—	1	59
2008	1	—	0	76
2009	2	—	1	29
2010	0	—	1	63
2011	2	—	0	170
2012	2	—	0	257
2013	1	—	0	322
2014	0	—	0	887
2015	0	—	0	1,657
2016	0	—	0	2,515
2017	1	—	0	2,878
2018	0	—	0	2,203
2019	0	—	1 (1)	9,350
2020	1	—	33	4,170
2021	0	—	0	3,790
2022	1	—	5 (5)	3,277
2023	1	—	0	4,565
2024	2	—	0	4,808
2025	1	—	0	3,545
2026	1	—	0	—

What is it indicated for?

The BiPAP S/T-D System is intended for hospital or institutional use for treatment of obstructive sleep apnea, respiratory failure, or respiratory insufficiency.

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/K951264 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951264: Bipap Model S/T-D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951264

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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