510(k) Report

510(k) · Cleared

Cleared

Respironics Silhouette Nasal Mask, Models 1003224 and 1003223

K000705510(k) AbbreviatedCleared Sep 8, 2000190-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 Sep 8, 2000 after a 190-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.

Decided
Sep 8, 2000
Review
190 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2007: 2 descendants cleared, 1 with a Class I recall12011: 2 descendants cleared2012: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK000705 Respironics Silhouette Nasal Mask, Models 1003224 and 1003223Respironics, Inc. · 2000
  2. Descendant · cites it directly · 4 of its ownK063268 Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · Recalled (Class I)
  3. Descendant · cites it directly · 3 of its ownK103174 Apex Medical Wizard Series Cpap MaskApex Medical Corp. · 2011
  4. Descendant · 2 generations on · 1 of its ownK182394 WiZARD 310/320 Series CPAP MaskApex Medical Corp. · 2019
  5. Descendant · 2 generations on · 1 of its ownK120920 Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow…Hsiner Company · 2012
  6. Descendant · 3 generations on · 0 of its ownK243023 WiZARD 520 Full Face MaskWellell, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007: 22011: 22012: 12019: 12020: 12024: 12025: 1
2007high 2 (2007) · low 0 (2008)2026

Class I recalls in this family

  • K063268 Cpap/Vpap Masks, Models 1225, 1205 and 1235cites it directly · 2007

Most influential descendants

Showing 5 of 9 · See all
  • K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · cites it directly4descendants
  • K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp. · 2011 · cites it directly3descendants
  • K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp. · 2019 · 2 generations on1descendant
  • K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company · 2012 · 2 generations on1descendant
  • K243023WiZARD 520 Full Face MaskWellell, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000705Respironics Silhouette Nasal Mask, Models 1003224 and 1003223Respironics, Inc.2000—
+1K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd.2007Class I
+1K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp.2011—
+2K182394WiZARD 310/320 Series CPAP MaskApex Medical Corp.2019—
+2K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner…Hsiner Company2012—
+3K243023WiZARD 520 Full Face MaskWellell, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200721
201120
201210
201910
202010
202410
202510
FIG. 1 — Lineage of K000705, 2000–2025Source: 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), 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 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? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235 Class IHsiner Co., Ltd.20074
K103174Apex Medical Wizard Series Cpap MaskApex Medical Corp.20113

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.

  • K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K063268 (Hsiner Co., Ltd., 2007) has gone furthest, with 4 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/K000705 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000705: Respironics Silhouette Nasal Mask, Models 1003224 and 1003223.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000705

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