510(k) · Cleared
ClearedBipap S/T-D 30 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Dec 20, 1996 as substantially equivalent to K883825 (Respironics, Inc., 1988) and 4 other predicates after a 396-day review. Its family tree reaches back 2 generations to 1983. 9 of the 51 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.
- Decided
- Dec 20, 1996
- Review
- 396 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K833786 (1983). 6 ancestors in all, the oldest K811102 (1981). 44 later devices descend from it, 2 citing it directly. 9 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 1 generation backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- This deviceK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- Descendant · cites it directly · 42 of its ownK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 14 of its ownK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK053168 Bipap FocusRespironics (Ireland) Limited · 2006 · Recalled
- Descendant · 3 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 3 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K982454Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · cites it directly42descendants
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 2 generations on14descendants
- K053168Bipap FocusRespironics (Ireland) Limited · 2006 · 2 generations on11descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 3 generations on10descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −1 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| 0 (this device) | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| +1 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| +2 | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | Class I |
| +2 | K053168 | Bipap Focus | Respironics (Ireland) Limited | 2006 | 1 |
| +3 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +3 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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.
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 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K883825 | Modified Sanders BI-PapeasySummary page 1…ame: BiPAP® S/T-D 30 Common Name: Continuous Ventilator, Passive Exhalation Port, Critical Care Classification: 868.5895, 73 MNT Predicate Device: Respironics BiPAP® (K883825) Respironics BiPAP® S/T-D System (K951264) Detachable Control Panel (K905540) Siemens Servo 900 (K811102) Healthdyne Quantumm P… | 1988 |
| * | K951264 | Bipap Model S/T-D Cleared while this submission was under review Summary page 1…us Ventilator, Passive Exhalation Port, Critical Care Classification: 868.5895, 73 MNT Predicate Device: Respironics BiPAP® (K883825) Respironics BiPAP® S/T-D System (K951264) Detachable Control Panel (K905540) Siemens Servo 900 (K811102) Healthdyne Quantumm Pressure Support Ventilator (K950331) Page… | 1996 |
| * | K905540 | Respironics Bipap Remote Control UnitSummary page 1…ort, Critical Care Classification: 868.5895, 73 MNT Predicate Device: Respironics BiPAP® (K883825) Respironics BiPAP® S/T-D System (K951264) Detachable Control Panel (K905540) Siemens Servo 900 (K811102) Healthdyne Quantumm Pressure Support Ventilator (K950331) Page 1 Premarket Notific… | 1991 |
| * | K811102 | Siemens-Elema AB Servo Ventilator 900 CSummary page 1…cation: 868.5895, 73 MNT Predicate Device: Respironics BiPAP® (K883825) Respironics BiPAP® S/T-D System (K951264) Detachable Control Panel (K905540) Siemens Servo 900 (K811102) Healthdyne Quantumm Pressure Support Ventilator (K950331) Page 1 Premarket Notification, Part A BiPAP S/T-D Sy… | 1981 |
| * | K950331 | Pressure Support Ventilatory Assist System (Psvas)Summary page 1…AP® (K883825) Respironics BiPAP® S/T-D System (K951264) Detachable Control Panel (K905540) Siemens Servo 900 (K811102) Healthdyne Quantumm Pressure Support Ventilator (K950331) Page 1 Premarket Notification, Part A BiPAP S/T-D System Section 16, 510(k) Summary Description of the BiPAP S… | 1995 |
What descends from it? (44)
See all 442 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 2 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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K982454 (Respironics, Inc., 1998) has gone furthest, with 42 descendants of its own.
- 4 other devices also cite its predicate K883825.
How does its category compare?
All MNT devicesMNT 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
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
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 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 30 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/K955324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955324: Bipap S/T-D 30 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955324
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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