510(k) · Cleared
ClearedSoyala Gel Vented
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weinmann Gerate Fur Medizin GmbH + Co. KG · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 9, 2008 as substantially equivalent to K060405 (Weinmann Gerate Fur Medizin GmbH + Co. KG, 2006) after a 30-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.
- Decided
- May 9, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060405 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK060405 Soyala, Soyala BlueWeinmann Gerate Fur Medizin GmbH + Co. KG · 2006
- This deviceK081014 Soyala Gel VentedWeinmann Gerate Fur Medizin GmbH + Co. KG · 2008
- Descendant · cites it directly · 0 of its ownK110884 Easyfit Silkgel Nasal MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2011
Most influential descendants
Showing 1 of 1 · See all- K110884Easyfit Silkgel Nasal MaskWeinmann Gerate Fur Medizin GmbH + Co. KG · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060405 | Soyala, Soyala Blue | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2006 | — |
| 0 (this device) | K081014 | Soyala Gel Vented | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2008 | — |
| +1 | K110884 | Easyfit Silkgel Nasal Mask | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (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 |
|---|---|---|---|
| * | K060405 | Soyala, Soyala BlueSummary page 1…fication: 21 CFR 868.5905, Class 1I, Product Code BZD Predicate Device Equivalence: Substantial equivalence isclaimed to SOYALA, cleared for commercial distribution per K060405. Device Description: The SOYALA GEL vented is a molded plastic mask, including an exhalation system, for the delivery of CPAP o… | 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 |
|---|---|---|---|
| K110884 | Easyfit Silkgel Nasal Mask | 2011 | 0 |
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?
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081014: Soyala Gel Vented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081014
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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