510(k) · Cleared
ClearedPerformax Pediatric SE Total Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Jul 10, 2012 as substantially equivalent to K092648 (Respironics Inc., Sleep & Home Respiratory Group, 2009) and 1 other predicate after a 130-day review. Its family tree reaches back 7 generations to 1991. 4 of the 50 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 10, 2012
- Review
- 130 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K902859 (1991). 49 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 4 of the 50 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 deviceK120639 Performax Pediatric SE Total Face MaskRespironics, Inc. · 2012
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) | 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 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 1 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 1 |
| 2007 | 3 | 0 |
| 2009 | 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.
4 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 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 |
|---|---|---|---|
| * | K092648 | Respironics Performax SE Total Face MaskSummary page 1…ion Name ICBK - Ventilator, continuous, facility use Product Code Predicate Device(s) Respironics PerforMax Youth SE Total Face Mask (K092648) Respironics Small Child Profile Lite Nasal Mask (K093416) Device Description The Perf… | 2009 |
| * | K093416 | Trilogy 200 VentilatorSummary page 1…Device(s) Respironics PerforMax Youth SE Total Face Mask (K092648) Respironics Small Child Profile Lite Nasal Mask (K093416) Device Description The PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 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.
- 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 · 3 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 21 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 17 of the 49 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K092648.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 PerforMax Pediatric SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (> 7 kg) who are appropriate candidates for noninvasive ventilation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120639: Performax Pediatric SE Total Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120639
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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