510(k) · Cleared
ClearedIvolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3B Medical, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Dec 23, 2013 as substantially equivalent to K030798 (Resmed, Ltd., 2003) and 2 other predicates after a 181-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Dec 23, 2013
- Review
- 181 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K952292 (1995). 34 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 6 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 5 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 4 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 3 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 2 generations backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- 1 generation backK112271 3B Willow3B Products, LLC · 2012 · Recalled
- This deviceK131901 Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −6 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −5 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −4 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −3 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −2 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −1 | K112271 | 3B Willow | 3B Products, LLC | 2012 | 1 |
| 0 (this device) | K131901 | Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2 | 3B Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 BZD? 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
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 |
|---|---|---|---|
| * | K030798 | Mirage Activa MaskSummary page 1…anufacturer: Resmed Trade Name: Mirage Activa LT Nasal Mask 510(k) Number: K030798 iVolve® Nasal Mask Series SectionS6: 510(k) Summary… | 2003 |
| * | K113127 | Mirage QuattroSummary page 2…facturer: Resmed Trade Name: Mirage Quattro Full Face Mask 510(k) Number: K113 127 Manufacturer: BMC Trade Name: Willow Nasal… | 2012 |
| * | K112271 | 3B WillowSummary page 2…Manufacturer: BMC Trade Name: Willow Nasal Mask 510(k) Number: K112271 Device Description: The iVolve® N2 and Nasal Masks are respiratory nasal mask interfa… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 34 ancestors have a recall of any class.
- 4 other devices also cite its predicate K030798.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 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) | — |
What is it indicated for?
The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.
The iVolve® Mask is:
1. to be used by adult patients (>66 lb/30 kg) for whom positive airway pressure has been prescribed.
2. intended for single-patient re-use in the home, hospital, and sub-acute environment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131901: Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131901
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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