510(k) · Cleared
ClearedDarlinghurst Vented, Darlinghurst NV-AAV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on May 21, 2015 as substantially equivalent to K071149 (Hans Rudolph, Inc., 2008) after a 154-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- May 21, 2015
- Review
- 154 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K936047 (1995). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 4 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- 3 generations backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- 2 generations backK030822 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV MasksHans Rudolph, Inc. · 2003
- 1 generation backK071149 Hri 6500, 6600 and 6700 Series V2MASKSHans Rudolph, Inc. · 2008
- This deviceK143603 Darlinghurst Vented, Darlinghurst NV-AAVResmed, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −4 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| −3 | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| −2 | K030822 | 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks | Hans Rudolph, Inc. | 2003 | — |
| −1 | K071149 | Hri 6500, 6600 and 6700 Series V2MASKS | Hans Rudolph, Inc. | 2008 | — |
| 0 (this device) | K143603 | Darlinghurst Vented, Darlinghurst NV-AAV | Resmed, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
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 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? (1)
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 |
|---|---|---|---|
| * | K071149 | Hri 6500, 6600 and 6700 Series V2MASKSSummary page 5…CBK Predicate Devices Hans Rudolph 6600 Series V2 Hans Rudolph 6700 Series V2 (K071149) (K071149) May, 2015 5… | 2008 |
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The Darlinghurst Vented mask is a non-invasive accessory used for channeling airflow to a patient from positive airway pressure (PAP) devices. The mask is: • to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure therapy has been prescribed • disposable devices, intended for short-term treatment (up to 7 days) of a single patient, in the hospital environment only. The Darlinghurst NV-AAV mask is a non-invasive…
Read the full statement (157 words)
The Darlinghurst Vented mask is a non-invasive accessory used for channeling airflow to a patient from
positive airway pressure (PAP) devices.
The mask is:
• to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure
therapy has been prescribed
• disposable devices, intended for short-term treatment (up to 7 days) of a single patient, in the
hospital environment only.
The Darlinghurst NV-AAV mask is a non-invasive accessory used for channeling airflow to a patient
from a positive airway pressure (PAP) device.
The mask is:
• to be used on patients weighing >66 lb (30 kg), for whom non-invasive positive airway pressure
therapy has been prescribed
• a disposable device, intended for short-term treatment (up to 7 days) of a single patient, in the
hospital environment only
• intended to be used with breathing circuits or positive pressure ventilation (PPV) devices that
provide their own method of venting expired or supplemental gases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143603: Darlinghurst Vented, Darlinghurst NV-AAV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143603
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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