510(k) · Cleared
ClearedNP15
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 Mar 11, 2011 as substantially equivalent to K082558 (Respironics, Inc., 2009) after a 190-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Mar 11, 2011
- Review
- 190 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945938 (1996). 8 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 3 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 2 generations backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- 1 generation backK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
- This deviceK102515 NP15Weinmann Gerate Fur Medizin GmbH + Co. KG · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −3 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −2 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| −1 | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
| 0 (this device) | K102515 | NP15 | Weinmann Gerate Fur Medizin GmbH + Co. KG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K082558 | Comfortlite Nasal MaskSummary page 1…s 1I, Product Code BZD Predicate Device Equivalence: Substantial equivalence is claimed to Respironics ComfortLite Nasal Mask, cleared for commercial distribution per K082558. An additional predicate, the Weinmann SOYALA Full Face Mask, cleared for commercial distribution per K061653, is referred to in… | 2009 |
| † | K061653 | Soyala Full Face Mask | 2006 |
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 15 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 8 ancestors has a recall.
- 4 other devices also cite its predicate K082558.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 NP 15 is intended for
*adult patients (> 30 kg) prescribed continuous positive airway pressure (CRAP) or bi-level therapy,
*multiple-patient use in a hospital or clinic environment after high-level disinfection,
*single-patient use in a home environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102515: NP15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102515
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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