510(k) Report

510(k) · Cleared

Cleared

Total Face Mask

K925920510(k) TraditionalCleared Jul 21, 1993240-day reviewClass II21 CFR 868.5905

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Respironics, Inc. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Jul 21, 1993 after a 240-day review. The FDA summary names no predicate by number. 16 later devices descend from it.

Decided
Jul 21, 1993
Review
240 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
0

16 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2007: 2 descendants cleared2024: 2 descendants cleared2009: 3 descendants cleared2010: 2 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2026: 1 descendant cleared2015: 2 descendants cleared1990200020102020
  1. This deviceK925920 Total Face MaskRespironics, Inc. · 1993
  2. Descendant · cites it directly · 15 of its ownK992969 Respironics Total Face MaskRespironics, Inc. · 1999
  3. Descendant · 2 generations on · 7 of its ownK072588 Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
  4. Descendant · 2 generations on · 6 of its ownK072592 Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007
  5. Descendant · 3 generations on · 5 of its ownK092648 Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009
  6. Descendant · 3 generations on · 4 of its ownK092043 Bipap Synchrony 2Respironics, Inc. · 2009

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1999: 12007: 22009: 32010: 22011: 12012: 22015: 22024: 22026: 1
1999high 3 (2009) · low 0 (2000)2026

Most influential descendants

Showing 5 of 16 · See all
  • K992969Respironics Total Face MaskRespironics, Inc. · 1999 · cites it directly15descendants
  • K072588Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007 · 2 generations on7descendants
  • K072592Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2007 · 2 generations on6descendants
  • K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on5descendants
  • K092043Bipap Synchrony 2Respironics, Inc. · 2009 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925920Total Face MaskRespironics, Inc.1993—
+1K992969Respironics Total Face MaskRespironics, Inc.1999—
+2K072588Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group2007—
+2K072592Performax Total Face MaskRespironics Inc., Sleep & Home Respiratory Group2007—
+3K092648Respironics Performax SE Total Face MaskRespironics Inc., Sleep & Home Respiratory Group2009—
+3K092043Bipap Synchrony 2Respironics, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200720
200930
201020
201110
201220
201520
202420
202610
FIG. 1 — Lineage of K925920, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992969Respironics Total Face MaskRespironics, Inc.199915

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?

  • Of its descendants, K992969 (Respironics, Inc., 1999) has gone furthest, with 15 descendants of its own.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007: 212008: 172009: 232010: 122011: 232012: 212013: 232014: 142015: 112016: 122017: 52018: 52019: 62020: 62021: 62022: 42023: 52024: 102025: 72026 (partial year): 10
2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007: 83 days median2008: 108 days median2009: 90 days median2010: 122 days median2011: 125 days median2012: 133 days median2013: 127 days median2014: 172 days median2015: 224 days median2016: 217 days median2017: 221 days median2018: 280 days median2019: 231 days median2020: 137 days median2021: 192 days median2022: 253 days median2023: 204 days median2024: 132 days median2025: 189 days median2026 (partial year): 214 days median
2007high 280 (2018) · low 83 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BZD

8in 2023

2007: 292008: 22009: 12011: 12019: 4, 4 Class I2023: 8, 7 Class I2026 (partial year): 2, 2 Class I
2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007: 652008: 672009: 1472010: 1432011: 1892012: 1392013: 822014: 862015: 1142016: 1182017: 1482018: 1012019: 1882020: 1262021: 6,0662022: 90,7682023: 27,9872024: 68,2622025: 60,279
2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200721832965
200817108267
200923901147
2010121220143
2011231251189
2012211330139
201323127082
201414172086
2015112240114
2016122170118
201752210148
201852800101
201962314 (4)188
202061370126
2021619206,066
20224253090,768
202352048 (7)27,987
202410132068,262
20257189060,279
2026102142 (2)—

More from Respironics, Inc.

173 FDA decisions under this applicant name. See the company

  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K243394AF531 Oro-Nasal SE Face MaskRespironics, Inc. · 2024
  • K231313Therapy Mask 3100 NC/SPRespironics, Inc. · 2023
  • K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
  • K210386Magneto Nasal MaskRespironics, Inc. · 20211 Class I recall

Recent decisions in BZD

The BZD category page

  • K260251BreathCare PAP III (YH-390N)Suzhou Yuyue Medical Technology Co., Ltd. · 2026
  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
  • K253553OrionResmed Corp · 2026
  • K254104ResScan EssentialsResmed Corp · 2026

https://510kreport.com/device/K925920 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925920: 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/K925920

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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