510(k) · Cleared
ClearedNasal Interface Model 7910
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthdyne Technologies, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Aug 4, 1998 after a 252-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 of the 44 devices in its family, counting itself, have a Class I recall. 43 later devices descend from it.
- Decided
- Aug 4, 1998
- Review
- 252 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 2 citing it directly. 7 of the 44 devices in this family, counting this one, have a Class I recall.
- This deviceK974453 Nasal Interface Model 7910Healthdyne Technologies, Inc. · 1998
- Descendant · cites it directly · 41 of its ownK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- Descendant · 2 generations on · 36 of its ownK082558 Comfortlite Nasal MaskRespironics, Inc. · 2009
- Descendant · 3 generations on · 19 of its ownK102746 Mirage FXResmed, Ltd. · 2010
- Descendant · 4 generations on · 9 of its ownK123979 Quattro AirResmed, Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 9 of its ownK102502 Golife Nasal MaskRespironics, Inc. · 2010
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 43 · See all- K053352Comfortlite Nasal MaskRespironics, Inc. · 2006 · cites it directly41descendants
- K082558Comfortlite Nasal MaskRespironics, Inc. · 2009 · 2 generations on36descendants
- K102746Mirage FXResmed, Ltd. · 2010 · 3 generations on19descendants
- K123979Quattro AirResmed, Ltd. · 2013 · 4 generations on9descendants
- K102502Golife Nasal MaskRespironics, Inc. · 2010 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974453 | Nasal Interface Model 7910 | Healthdyne Technologies, Inc. | 1998 | — |
| +1 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| +2 | K082558 | Comfortlite Nasal Mask | Respironics, Inc. | 2009 | — |
| +3 | K102746 | Mirage FX | Resmed, Ltd. | 2010 | — |
| +4 | K123979 | Quattro Air | Resmed, Ltd. | 2013 | 1 |
| +3 | K102502 | Golife Nasal Mask | Respironics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 1 |
| 2013 | 7 | 1 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 4 | 2 |
| 2017 | 3 | 1 |
| 2018 | 2 | 1 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
7 devices in this family have a Class I recall. 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (43)
See all 432 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K121631Simple T Nasal MaskRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132887Airfit N10Resmed, Ltd. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153563AirFit F20Resmed, Ltd. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K170924AirFit F20Resmed, Ltd. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K161978AirFit N20Resmed, Ltd. · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K171212AirFit N20Resmed, Ltd. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- Of its descendants, K053352 (Respironics, Inc., 2006) has gone furthest, with 41 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 Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external…
Read the full statement (120 words)
The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974453 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974453: Nasal Interface Model 7910.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974453
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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