510(k) · Cleared
ClearedSimple T Pediatric 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 Apr 15, 2016 as substantially equivalent to K140268 (Respironics, Inc., 2014) and 1 other predicate after a 354-day review. Its family tree reaches back 7 generations to 1991. 5 of the 35 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 15, 2016
- Review
- 354 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K902859 (1991). 34 ancestors in all, the oldest K841279 (1984). No later device cites it as a predicate yet. 5 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK961687 EVITA 4Drager, Inc. · 1996
- 5 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 4 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 3 generations backK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- 2 generations backK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 1 generation backK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
- This deviceK151120 Simple T Pediatric Nasal MaskRespironics, Inc. · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −5 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −4 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −3 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| −2 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −1 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| 0 (this device) | K151120 | Simple T Pediatric Nasal Mask | Respironics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 1 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 1 |
| 2007 | 1 | 0 |
| 2014 | 1 | 1 |
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.
5 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? (2)
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 |
|---|---|---|---|
| * | K140268 | Simple T Youth Nasal MaskSummary page 4…roduct Code BZD – Ventilator, non-continuous Product Code (respirator) Predicate Device(s) Respironics Simple T Youth Nasal Mask (K140268) Respironics Profile Lite Small Child (K093416) Reference Device Respiro… | 2014 |
| * | K093416 | Trilogy 200 VentilatorSummary page 4…spirator) Predicate Device(s) Respironics Simple T Youth Nasal Mask (K140268) Respironics Profile Lite Small Child (K093416) Reference Device Respironics Trilogy 200 (K093416) Indications for Use This mask is intended to provide… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K140268Simple T Youth Nasal MaskRespironics, Inc. · 2014 · Direct predicate · ◆ in the 2014 ancestors bar of FIG. 11 Class I recall
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 17 of the 34 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K140268.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
This mask is intended to provide an interface for application of non-invasive ventilation to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients greater than 10 kg/22 lbs (>10 kg/22 lbs) for whom non-invasive ventilation has been prescribed. Use of this mask is limited by the indications for use of the compatible therapy device with respect to patient weight.
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/K151120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151120: Simple T Pediatric 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/K151120
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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