510(k) · Cleared
Recalled · 2007Bipap Vision Ventilatory Support
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 Nov 3, 1998 as substantially equivalent to K955324 (Respironics, Inc., 1996) after a 111-day review. Its family tree reaches back 3 generations to 1983. 9 of the 50 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 3, 1998
- Review
- 111 days
- Class
- Class II
- Product code
- MNT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K833786 (1983). 7 ancestors in all, the oldest K811102 (1981). 42 later devices descend from it, 7 citing it directly. 9 of the 50 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 2 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 1 generation backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- This deviceK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998
- Descendant · cites it directly · 14 of its ownK082660 V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Recalled (Class I)
- Descendant · cites it directly · 11 of its ownK053168 Bipap FocusRespironics (Ireland) Limited · 2006 · Recalled
- Descendant · 2 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 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)
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 42 · See all- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · cites it directly14descendants
- K053168Bipap FocusRespironics (Ireland) Limited · 2006 · cites it directly11descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 2 generations on10descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on8descendants
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −2 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −1 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| 0 (this device) | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | — |
| +1 | K082660 | V60 Ventilator, Model V8000 | Respironics California, Inc. | 2009 | Class I |
| +1 | K053168 | Bipap Focus | Respironics (Ireland) Limited | 2006 | 1 |
| +2 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +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 |
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 |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K955324 | Bipap S/T-D 30 SystemSummary page 1…Murrysville, PA 15668 Telephone: (724) 733-0200 21 CFR 868.5895,73 MNT Ventilator, Continuous BiPAP Vision® Ventilatory Support System Respironics BiPAP S/T-D 30 - K955324 Respironics, Inc. ‘B_iPAF and BiPAP Vision are registered trademarks of Respironics, Inc. Premarket Notification… | 1996 |
What descends from it? (42)
See all 427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082660 | V60 Ventilator, Model V8000 Class I | 2009 | 14 |
| K053168 | Bipap Focus | 2006 | 11 |
| K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 | 2007 | 6 |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | 2022 | 2 |
| K023350 | Esprit Ventilator with Respiratory Mechanics Class I | 2002 | 2 |
| K072885 | Carina System, Model 8419350; Carina Basic Device, Model 5704110 Class I | 2008 | 0 |
| K031896 | Nasal-Air Critical Care | 2004 | 0 |
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2007 | Not classified | Z-1057-2008 | Environmental control | Foreign material: Glass fragments may present in the plastic bag material used to ship components. |
| Oct 15, 2007 | Not classified | Z-1085-2008 | 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.
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · Cites it directly · ◆ 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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- 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 9; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K082660 (Respironics California, Inc., 2009) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K955324.
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 Respironics BiPAP Vision® Ventilatory Support System is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non-invasive applications. The BiPAP Vision is intended for use in a…
Read the full statement (132 words)
The Respironics BiPAP Vision® Ventilatory Support System is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non-invasive applications.
The BiPAP Vision is intended for use in a hospital environment (including sleep labs, respiratory care units) or alternate care site (e.g., transitional care centers, skilled nursing homes, ambulatory care centers) by respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician. The BiPAP Vision is used with various combinations of Respironics-approved patient circuit accessories, such as patient interface devices (masks and tracheal tube adapter), humidifiers, and circuit tubing.
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/K982454 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982454: Bipap Vision Ventilatory Support.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982454
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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