510(k) Report

510(k) · Cleared

Cleared

Oxygen Diverter Valve

K033914510(k) TraditionalCleared Apr 22, 2004126-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

Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Apr 22, 2004 as substantially equivalent to K963250 (Respironics, Inc., 1996) and 1 other predicate after a 126-day review. Its family tree reaches back 1 generation to 1996.

Decided
Apr 22, 2004
Review
126 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K963250 (1996). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK963250 · Pressure Valve · Respironics, Inc. · 1996199619982000200220042006
Other ancestors, by generation 1 generation back: 1 other ancestor K963250 · Pressure Valve · Respironics, Inc. · 19960
  1. Root · 1 generation backK963250 Pressure ValveRespironics, Inc. · 1996
  2. This deviceK033914 Oxygen Diverter ValveResmed, Ltd. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963250Pressure ValveRespironics, Inc.1996—
0 (this device)K033914Oxygen Diverter ValveResmed, Ltd.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K033914, 1996–2004Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K963250Pressure Valve
Summary page 1
…mmon Name: Oxygen Diverter Valve Classification Name: Accessory for Ventilator, Passive exhaust port Predicate Devices: 1: K963250 Pressure Valve 2: K982530 Mirage Full Face Mask Device Description: The Oxygen Diverter Valve i…
Respironics, Inc.1996—
*K982530Sullivan Mirage Full Face Mask
Summary page 1
…ion Name: Accessory for Ventilator, Passive exhaust port Predicate Devices: 1: K963250 Pressure Valve 2: K982530 Mirage Full Face Mask Device Description: The Oxygen Diverter Valve is an in-line one-way valve…
Resmed, Ltd.1998—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.

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)—

What is it indicated for?

The Oxygen Diverter Valve is an accessory to a CPAP or Bilevel Flow Generator intended to prevent the backflow of oxygen or water when the unit is not operating

Indications for use as stated in the FDA summary.

More from Resmed, Ltd.

103 FDA decisions under this applicant name. See the company

  • K183512Moore Park MaskResmed, Ltd. · 20191 Class I recall
  • K180497Scone MaskResmed, Ltd. · 2018
  • K172875Astral 100/150Resmed, Ltd. · 20182 Class I recalls
  • K170924AirFit F20Resmed, Ltd. · 20182 Class I recalls
  • K171212AirFit N20Resmed, Ltd. · 20171 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/K033914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033914: Oxygen Diverter Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033914

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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