510(k) Report

510(k) · Cleared

Cleared

Respcare Face Mask

K052227510(k) TraditionalCleared Oct 28, 200573-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

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

Cleared on Oct 28, 2005 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Oct 28, 2005
Review
73 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared20052010201520202025
  1. This deviceK052227 Respcare Face MaskRespcare, Inc. · 2005
  2. Descendant · cites it directly · 0 of its ownK062224 Respcare Hybrid AV MaskRespcare, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K062224Respcare Hybrid AV MaskRespcare, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052227Respcare Face MaskRespcare, Inc.2005—
+1K062224Respcare Hybrid AV MaskRespcare, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K052227, 2005–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K062224Respcare Hybrid AV MaskRespcare, Inc.20060

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, K062224 (Respcare, Inc., 2006) has gone furthest, with 0 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 Respcare, Inc.

3 FDA decisions under this applicant name. See the company

  • K062224Respcare Hybrid AV MaskRespcare, Inc. · 2006
  • K052249UtopiaRespcare, Inc. · 2005

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/K052227 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052227: Respcare 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/K052227

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026