510(k) · Cleared
Recalled · 2008Bipap Focus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics (Ireland) Limited · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Jan 4, 2006 as substantially equivalent to K982454 (Respironics, Inc., 1998) and 2 other predicates after a 51-day review. Its family tree reaches back 4 generations to 1983. 11 later devices descend from it. It has been recalled once.
- Decided
- Jan 4, 2006
- Review
- 51 days
- Class
- Class II
- Product code
- MNS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K833786 (1983). 15 ancestors in all, the oldest K811102 (1981). 11 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 3 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 2 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 1 generation backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- This deviceK053168 Bipap FocusRespironics (Ireland) Limited · 2006
- Descendant · cites it directly · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK090398 Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 2 of its ownK130538 Winx Sleep Therapy SystemApnicure, Inc. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · cites it directly10descendants
- K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · 2 generations on5descendants
- K122130Winx Sleep Therapy SystemApnicure, Inc. · 2012 · 3 generations on3descendants
- K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 2009 · 2 generations on3descendants
- K130538Winx Sleep Therapy SystemApnicure, Inc. · 2013 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −3 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −2 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −1 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| 0 (this device) | K053168 | Bipap Focus | Respironics (Ireland) Limited | 2006 | — |
| +1 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +2 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
| +3 | K122130 | Winx Sleep Therapy System | Apnicure, Inc. | 2012 | — |
| +2 | K090398 | Provent Professional Sleep Apnea Therapy | Ventus Medical, Inc. | 2009 | 1 |
| +3 | K130538 | Winx Sleep Therapy System | Apnicure, Inc. | 2013 | — |
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 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 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.
Planning a device in MNS? 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 MNS device
- #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K982454 | Bipap Vision Ventilatory SupportSummary page 4…y use (MNT) Device: Model - BiPAP Focus Predicate Devices: Respironics - Vision - K982454 Harmony K984407 and K031656 Device Description: The BiPAP Focus is a non-invasive ventilat… | 1998 |
| * | K984407 | Bipap Harmony S/T, Model 1001445Summary page 4…ice: Model - BiPAP Focus Predicate Devices: Respironics - Vision - K982454 Harmony K984407 and K031656 Device Description: The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes: 1. Conti… | 1999 |
| * | K031656 | Bipap Harmony Ventilatory Support SystemSummary page 4…Model - BiPAP Focus Predicate Devices: Respironics - Vision - K982454 Harmony K984407 and K031656 Device Description: The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes: 1. Continuous positi… | 2003 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071560 | Provent Nasal Dilator, Model BR2 | 2008 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2008 | Not classified | Z-1606-2009 | Component design/selection | Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K071560 (Ventus Medical, Inc., 2008) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K982454.
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, 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 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053168: Bipap Focus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053168
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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