510(k) · Cleared
ClearedIT Nasal Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innomed Technologies · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 4, 2005 as substantially equivalent to K991648 (Respironics, Inc., 1999) and 2 other predicates after a 98-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- May 4, 2005
- Review
- 98 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K833786 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −2 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −1 | K991648 | Reusable Contour II Nasal Mask | Respironics, Inc. | 1999 | — |
| 0 (this device) | K050171 | IT Nasal Mask | Innomed Technologies | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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? (3)
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 |
|---|---|---|---|
| * | K991648 | Reusable Contour II Nasal MaskSummary page 1…68.5895, 73 MNS Common/Usual Name Ventilator, continuous, non-life supporting (accessory to) Proprietary Name IT Nasal Mask Predicate Devices K991648 -- Respironics Contour Nasal Mask K974453 - Respironics Comfort Classic Nasal Mask… | 1999 |
| * | K974453 | Nasal Interface Model 7910Summary page 1…non-life supporting (accessory to) Proprietary Name IT Nasal Mask Predicate Devices K991648 -- Respironics Contour Nasal Mask K974453 - Respironics Comfort Classic Nasal Mask K984428 -- ResMed Mirage Nasal Mask K9… | 1998 |
| * | K984428 | Sullivan Autoset Nasal Cpap SystemSummary page 1…k Predicate Devices K991648 -- Respironics Contour Nasal Mask K974453 - Respironics Comfort Classic Nasal Mask K984428 -- ResMed Mirage Nasal Mask K984407 -- Respironics Bipap Harmony S/T, and… | 1999 |
| † | K984407 | Bipap Harmony S/T, Model 1001445 | 1999 |
| † | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | 1997 |
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 22 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 6 ancestors has a recall.
- 8 other devices also cite its predicate K991648.
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 InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation devices capable of generating pressures up to 20cm H 20. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency.
The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050171: IT 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/K050171
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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