510(k) · Cleared
ClearedPerformax Pediatric EE Total Face 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 Jul 17, 2012 as substantially equivalent to K092043 (Respironics, Inc., 2009) and 1 other predicate after a 144-day review. Its family tree reaches back 7 generations to 1997. 4 of the 50 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 17, 2012
- Review
- 144 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962517 (1997). 49 ancestors in all, the oldest K833786 (1983). 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 backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 6 generations backK992530 Bipap Synchrony HCRespironics, Inc. · 2000
- 5 generations backK012323 Bipap Synchrony Ventilatory Support SystemRespironics, Inc. · 2001
- 4 generations backK031656 Bipap Harmony Ventilatory Support SystemRespironics, Inc. · 2003
- 3 generations backK063533 Bipap SynchronyRespironics, Inc. · 2007
- 2 generations backK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- 1 generation backK092043 Bipap Synchrony 2Respironics, Inc. · 2009
- This deviceK120562 Performax Pediatric EE 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 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −6 | K992530 | Bipap Synchrony HC | Respironics, Inc. | 2000 | — |
| −5 | K012323 | Bipap Synchrony Ventilatory Support System | Respironics, Inc. | 2001 | — |
| −4 | K031656 | Bipap Harmony Ventilatory Support System | Respironics, Inc. | 2003 | — |
| −3 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| −2 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| −1 | K092043 | Bipap Synchrony 2 | Respironics, Inc. | 2009 | — |
| 0 (this device) | K120562 | Performax Pediatric EE Total Face Mask | Respironics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 1 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 1 |
| 2010 | 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.
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 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 |
|---|---|---|---|
| * | K092043 | Bipap Synchrony 2Summary page 1…on Name /BZD - Ventilator, Non-Continuous (Respirator) Product Code Predicate Device(s) Respironics PerforMax Youth EE Total Face Mask (K092043) Respironics Small Child Profile Lite Nasal Mask (K(093416) Device Description PerforMa… | 2009 |
| * | K093416 | Trilogy 200 VentilatorSummary page 2…logical characteristics to the previously cleared devices (Respironics PerforMax Youth EE Total Face Mask, K(092043, and Respironics Small Child Profile Lite Nasal Mask, K09341 6): 1. Same intended use 2. Same operating principle 3. Same technology 4. Similar device design 5. Similar ph… | 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 · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of 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 15 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 17 of the 49 ancestors have a recall of any class; 4 have a Class I recall.
- 2 other devices also cite its predicate K092043.
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?
PerforMax Pediatric EE Total Face Mask is intended to provide an interface for application of non-invasive positive airway pressure delivered to patients by a device such as a CPAP or bi-level system. 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) for whom positive airway pressure therapy has been prescribed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120562: Performax Pediatric EE 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/K120562
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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