510(k) · Cleared
ClearedReusable Contour II 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 May 28, 1999 as substantially equivalent to K951264 (Respironics, Inc., 1996) after a 15-day review. Its family tree reaches back 2 generations to 1983. 9 of the 62 devices in its family, counting itself, have a Class I recall. 58 later devices descend from it.
- Decided
- May 28, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K833786 (1983). 3 ancestors in all. 58 later devices descend from it, 9 citing it directly. 9 of the 62 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 1 generation backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- This deviceK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
- Descendant · cites it directly · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- Descendant · 2 generations on · 11 of its ownK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 10 of its ownK092835 Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2010
- Descendant · 2 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 3 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 58 · See all- K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · cites it directly28descendants
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations on11descendants
- K092835Comfortgel Nasal MaskRespironics Inc., Sleep & Home Respiratory Group · 2010 · cites it directly10descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 2 generations on10descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −1 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| 0 (this device) | K991648 | Reusable Contour II Nasal Mask | Respironics, Inc. | 1999 | — |
| +1 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| +2 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| +1 | K092835 | Comfortgel Nasal Mask | Respironics Inc., Sleep & Home Respiratory Group | 2010 | — |
| +2 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +3 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 1 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 1 |
| 2011 | 9 | 2 |
| 2012 | 7 | 2 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 0 |
| 2021 | 3 | 1 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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.
9 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? (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 |
|---|---|---|---|
| * | K951264 | Bipap Model S/T-D Our OCR of the scanned summary read K951284, FDA’s number for R&D Batteries, Inc. Part Numbers 5137, 5140, 5142 and 5155 (R & D Batteries, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Respironics BiPAP S/T-D System”. | 1996 |
What descends from it? (58)
See all 589 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071509 | Bipap Synchrony 2 Ventilatory Support System | 2007 | 28 |
| K092835 | Comfortgel Nasal Mask | 2010 | 10 |
| K091843 | Comfort Twin Nasal Mask | 2009 | 5 |
| K063268 | Cpap/Vpap Masks, Models 1225, 1205 and 1235 Class I | 2007 | 4 |
| K103174 | Apex Medical Wizard Series Cpap Mask | 2011 | 3 |
| K013738 | Weinmann Somnomask | 2002 | 3 |
| K102317 | IQ Ventilation Nasal Mask | 2011 | 2 |
| K091066 | Comfort Twin Nasal Mask | 2009 | 0 |
| K050171 | IT Nasal Mask | 2005 | 0 |
Has anything in its family been recalled? (9 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.
- K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071509 (Respironics Inc., Sleep & Home Respiratory Group, 2007) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K951264.
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 Respironics Reusable Contour II Nasal Mask is intended to provide an interface for
application of Respironics bi-level or CPAP therapy to patients.
For single patient use in the home or hospital/institutional environment. The mask is to
be used on adult patients (>30kg) for whom bi-level or CPAP therapy has been
prescribed using a Respironics bi-level or CPAP system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991648: Reusable Contour II Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991648
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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