510(k) · Cleared
ClearedC2 Nasal Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Feb 19, 2004 as substantially equivalent to K020641 (Worldwide Medical Technologies, LLC, 2002) after a 79-day review. Its family tree reaches back 2 generations to 1990. 9 later devices descend from it.
- Decided
- Feb 19, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900164 (1990). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK900164 Airway Delivery & Management (Adam) Nasal Ventila.Puritan Bennett Corp. · 1990
- 1 generation backK020641 Spiritus (TM) Respiratory System #SRS 001Worldwide Medical Technologies, LLC · 2002
- This deviceK033759 C2 Nasal MaskRespironics, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK042130 Aura Cpap Patient InterfaceAeiomed, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK132127 Transcend AutoSomnetics International, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK121374 ZI BlowerDeshum Medical · 2013
- Descendant · 2 generations on · 1 of its ownK072993 Reusable Headrest with Nasal SealAeiomed, Inc. · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K042130Aura Cpap Patient InterfaceAeiomed, Inc. · 2004 · cites it directly8descendants
- K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010 · 2 generations on5descendants
- K132127Transcend AutoSomnetics International, Inc. · 2013 · 3 generations on1descendant
- K121374ZI BlowerDeshum Medical · 2013 · 3 generations on1descendant
- K072993Reusable Headrest with Nasal SealAeiomed, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900164 | Airway Delivery & Management (Adam) Nasal Ventila. | Puritan Bennett Corp. | 1990 | — |
| −1 | K020641 | Spiritus (TM) Respiratory System #SRS 001 | Worldwide Medical Technologies, LLC | 2002 | — |
| 0 (this device) | K033759 | C2 Nasal Mask | Respironics, Inc. | 2004 | — |
| +1 | K042130 | Aura Cpap Patient Interface | Aeiomed, Inc. | 2004 | — |
| +2 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| +3 | K132127 | Transcend Auto | Somnetics International, Inc. | 2013 | — |
| +3 | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| +2 | K072993 | Reusable Headrest with Nasal Seal | Aeiomed, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K020641 | Spiritus (TM) Respiratory System #SRS 001Summary page 1…ventilator Predicate Devices Worldwide Medical Technologies, Inc. Spiritus Respiratory System (K020641) Reason for submission New Device Substantial Equivalence This premarket notification submissio… | 2002 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042130 | Aura Cpap Patient Interface | 2004 | 8 |
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 14 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042130 (Aeiomed, Inc., 2004) has gone furthest, with 8 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) | — |
What is it indicated for?
The C2 Nasal Mask is intended to provide an interface for application of prescribed CPAP or Bi-level therapy.
The mask is reusable and for single patient use only. It is intended for adult patients in a home or hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033759: C2 Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033759
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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