510(k) · Cleared
Recalled · Class II · 20233B Willow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3B Products, LLC · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Feb 16, 2012 as substantially equivalent to K042403 (Resmed, Ltd., 2004) and 2 other predicates after a 192-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 16, 2012
- Review
- 192 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 6 generations to K952292 (1995). 31 ancestors in all, the oldest K900164 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 5 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 4 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 3 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 2 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 1 generation backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- This deviceK112271 3B Willow3B Products, LLC · 2012
- Descendant · cites it directly · 0 of its ownK131901 Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131901Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N23B Medical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −5 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −4 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −3 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −2 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −1 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| 0 (this device) | K112271 | 3B Willow | 3B Products, LLC | 2012 | — |
| +1 | 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 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K042403 | Mirage SwiftSummary page 1…Manufacturer: Resmed Trade Name: Mirage Swift 11 5 10(k) Number: K042403 Manufacturer: Respironics Trade Name: Comfor… | 2004 |
| * | K082558 | Comfortlite Nasal MaskSummary page 1…Manufacturer: Respironics Trade Name: ComfortLite 2 5 10(k) Number: K082558 Manufacturer: Fisher & Paykel Trade Name: Op… | 2009 |
| * | K063036 | Opus HC482 Direct Nasal MaskSummary page 1…Manufacturer: Fisher & Paykel Trade Name: Opus 360 5 10(k) Number: K063036 Device Description: The 313WillowTM is a mask interface, of the nasal pillow variety,… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131901 | Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2 | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2023 | Class II | Z-2740-2026 | Labeling Change Control | Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K131901 (3B Medical, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K042403.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 WillowTM channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow TM is:
(1) to be used by adult patients (>661b / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed.
(2) to be used for single-patient reuse in the home environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112271: 3B Willow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112271
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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