510(k) · Cleared
ClearedBreeze Sleepgear with Dreamseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 6, 2000 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 6, 2000
- Review
- 68 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK002001 Breeze Sleepgear with DreamsealPuritan Bennett Corp. · 2000
- Descendant · cites it directly · 3 of its ownK013738 Weinmann SomnomaskGottlieb Weinmann Geraete Fuer Medizin Und Arbeits · 2002
- Descendant · 2 generations on · 2 of its ownK061653 Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2006
- Descendant · 3 generations on · 1 of its ownK073673 Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG · 2008
- Descendant · 4 generations on · 0 of its ownK112167 Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2011
- Descendant · cites it directly · 0 of its ownK090804 Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K013738Weinmann SomnomaskGottlieb Weinmann Geraete Fuer Medizin Und Arbeits · 2002 · cites it directly3descendants
- K061653Soyala Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2006 · 2 generations on2descendants
- K073673Soyala Full Face Mask Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG · 2008 · 3 generations on1descendant
- K112167Soyala Silkgel Full Face MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2011 · 4 generations on0descendants
- K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002001 | Breeze Sleepgear with Dreamseal | Puritan Bennett Corp. | 2000 | — |
| +1 | K013738 | Weinmann Somnomask | Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits | 2002 | — |
| +2 | K061653 | Soyala Full Face Mask | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006 | — |
| +3 | K073673 | Soyala Full Face Mask Gel Vented | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008 | — |
| +4 | K112167 | Soyala Silkgel Full Face Mask | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011 | — |
| +1 | K090804 | Nasal Aire II Pediatric, Model 5 Sizes, Model TBD | Innomed Technologies, Inc./Respcare, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013738 (Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits, 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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) | — |
https://510kreport.com/device/K002001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002001: Breeze Sleepgear with Dreamseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026