510(k) · Cleared
ClearedPersonalized Therapy Comfort Settings (PTCS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Corp · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Dec 5, 2025 as substantially equivalent to K250624 (Resmed Corp, 2025) after a 189-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Dec 5, 2025
- Review
- 189 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K913396 (1992). 54 ancestors in all, the oldest K905404 (1991). No later device cites it as a predicate yet.
- Root · 13 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 9 generations between
- 3 generations backK200565 GalapogosResmed Corp · 2021
- 2 generations backK241216 myAirResmed Corp · 2024
- 1 generation backK250624 myAirResmed Corp · 2025
- This deviceK251657 Personalized Therapy Comfort Settings (PTCS)Resmed Corp · 2025
Show all 13 generations
- Root · 13 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 12 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 11 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 10 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 9 generations backK040576 Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH · 2004
- 8 generations backK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
- 7 generations backK070263 ApnealinkResmed Germany, Inc. · 2007
- 6 generations backK083575 Apnealink Plus, Model: 22328Resmed Germany, Inc. · 2009
- 5 generations backK140124 S9 EloueraResmed Corp · 2014
- 4 generations backK160836 Menai SystemResmed, Ltd. · 2016
- 3 generations backK200565 GalapogosResmed Corp · 2021
- 2 generations backK241216 myAirResmed Corp · 2024
- 1 generation backK250624 myAirResmed Corp · 2025
- This deviceK251657 Personalized Therapy Comfort Settings (PTCS)Resmed Corp · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −12 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −11 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −10 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −9 | K040576 | Micromesam Basic-Set | Map Medizintechnik Fur Arzt Und Patient GmbH | 2004 | — |
| −8 | K061405 | Apnealink, Model 22302 | Resmed Germany, Inc. | 2006 | — |
| −7 | K070263 | Apnealink | Resmed Germany, Inc. | 2007 | — |
| −6 | K083575 | Apnealink Plus, Model: 22328 | Resmed Germany, Inc. | 2009 | — |
| −5 | K140124 | S9 Elouera | Resmed Corp | 2014 | — |
| −4 | K160836 | Menai System | Resmed, Ltd. | 2016 | — |
| −3 | K200565 | Galapogos | Resmed Corp | 2021 | — |
| −2 | K241216 | myAir | Resmed Corp | 2024 | — |
| −1 | K250624 | myAir | Resmed Corp | 2025 | — |
| 0 (this device) | K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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.
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? (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 |
|---|---|---|---|
| * | K250624 | myAirSummary page 5…Classification Name: Noncontinuous ventilator (IPPB) Product Code: BZD Predicate Device: myAir K250624 Submission Reason: New device 510(k) Summary… | 2025 |
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 33 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 54 ancestors have a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Personalized Therapy Comfort Settings (“PTCS”) is an optional software accessory indicated for use by healthcare professionals and patients, providing recommended non-prescription comfort settings options to support patients when using their compatible Resmed PAP therapy device. The outputs provided by PTCS are optional recommendations and are not required to use the therapy device. It is intended for use in a home or clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251657: Personalized Therapy Comfort Settings (PTCS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251657
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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