510(k) · Cleared
ClearedSimple T 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 Mar 30, 2012 after a 72-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 5 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Mar 30, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- This deviceK120145 Simple T Nasal MaskRespironics, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK121631 Simple T Nasal MaskRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK140980 TI Nasal MaskRespironics, Inc. · 2015 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK210844 DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK253166 F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd. · 2026
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K121631Simple T Nasal MaskRespironics, Inc. · 2012 · cites it directly3descendants
- K140980TI Nasal MaskRespironics, Inc. · 2015 · 2 generations on2descendants
- K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021 · 3 generations on1descendant
- K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120145 | Simple T Nasal Mask | Respironics, Inc. | 2012 | — |
| +1 | K121631 | Simple T Nasal Mask | Respironics, Inc. | 2012 | Class I |
| +2 | K140980 | TI Nasal Mask | Respironics, Inc. | 2015 | Class I |
| +3 | K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021 | — |
| +4 | K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 2015 | 1 | 1 |
| 2021 | 1 | 0 |
| 2026 | 1 | 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.
2 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121631 | Simple T Nasal Mask Class I | 2012 | 3 |
Has anything in its family been recalled? (2 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.
What does this lineage say?
- Of its descendants, K121631 (Respironics, Inc., 2012) has gone furthest, with 3 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. 2012, 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 Simple T Nasal Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66 lbs (30 kg).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120145 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120145: Simple T 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/K120145
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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