510(k) · Cleared
ClearedRespironics Performax SE Total Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics Inc., Sleep & Home Respiratory Group · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 18, 2009 as substantially equivalent to K072450 (Respironics California, Inc., 2007) and 1 other predicate after a 112-day review. Its family tree reaches back 5 generations to 1983. 1 of the 22 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Dec 18, 2009
- Review
- 112 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K833786 (1983). 16 ancestors in all, the oldest K811102 (1981). 5 later devices descend from it, 2 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
- 4 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- 3 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- 2 generations backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- 1 generation backK072450 Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc. · 2007
- This deviceK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
- Descendant · cites it directly · 3 of its ownK101129 Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK150638 AF541 SE Full Face MaskRespironics, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK251888 VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243394 AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK120639 Performax Pediatric SE Total Face MaskRespironics, Inc. · 2012
Class I recalls in this family
- K981072 Esprit Ventilator2 generations back · 1998
Most influential descendants
Showing 5 of 5 · See all- K101129Esprit Ventilator with AF531 SE Full Face MaskRespironics, Inc. · 2010 · cites it directly3descendants
- K150638AF541 SE Full Face MaskRespironics, Inc. · 2015 · 2 generations on1descendant
- K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026 · 2 generations on0descendants
- K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024 · 2 generations on0descendants
- K120639Performax Pediatric SE Total Face MaskRespironics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K833786 | Microprocessor Ventilator 7200 | Puritan Bennett Corp. | 1983 | — |
| −4 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| −3 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| −2 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| −1 | K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 | Respironics California, Inc. | 2007 | — |
| 0 (this device) | K092648 | Respironics Performax SE Total Face Mask | Respironics Inc., Sleep & Home Respiratory Group | 2009 | — |
| +1 | K101129 | Esprit Ventilator with AF531 SE Full Face Mask | Respironics, Inc. | 2010 | — |
| +2 | K150638 | AF541 SE Full Face Mask | Respironics, Inc. | 2015 | — |
| +2 | K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | 2026 | — |
| +2 | K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024 | — |
| +1 | K120639 | Performax Pediatric SE Total Face Mask | Respironics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 1 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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.
1 device in this family has 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Summary page 1…Classification Reference 21 CFR 868.5895 Product Code CBK - Continuous ventilator Predicate Device(s) Respironics Esprit Ventilator (K072450) Respironics Performax SE Total Face Mask (K072588) Labeling Draft Labeli… | 2007 |
| * | K072588 | Performax SE Total Face MaskSummary page 1…Continuous ventilator Predicate Device(s) Respironics Esprit Ventilator (K072450) Respironics Performax SE Total Face Mask (K072588) Labeling Draft Labeling can be found in Tab 5. Intended Use The ESPRIT ventilator is… | 2007 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K101129 (Respironics, Inc., 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in. either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and…
Read the full statement (95 words)
The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in. either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for user adjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 6OLJmin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092648 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092648: Respironics Performax SE Total Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092648
Report an extraction error
Are you the manufacturer?
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