510(k) · Cleared
ClearedF&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Sep 10, 2025 as substantially equivalent to K203449 (Fisher & Paykel Healthcare, Ltd., 2021) after a 61-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Sep 10, 2025
- Review
- 61 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003894 (2001). 13 ancestors in all, the oldest K982530 (1998). No later device cites it as a predicate yet.
- Root · 8 generations backK003894 Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2001 · Recalled
- 7 generations backK023559 Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003
- 6 generations backK033087 Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- 5 generations backK040506 Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- 4 generations backK060044 Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd. · 2006
- 3 generations backK083122 Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd. · 2009
- 2 generations backK173060 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard…Fisher and Paykel Healthcare Limited · 2018
- 1 generation backK203449 F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd. · 2021
- This deviceK252173 F&P OptiNIV Hospital Vented Full Face Mask Compatible with…Fisher & Paykel Healthcare, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2001 | 6 |
| −7 | K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −6 | K033087 | Oracle Oral Mask, Model HC451A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| −5 | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| −4 | K060044 | Acute Care Face Mask, Model RT040 | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −3 | K083122 | Hospital Full Face Mask Non Vented, Model: RT041 | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| −2 | K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | Fisher and Paykel Healthcare Limited | 2018 | — |
| −1 | K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | 2021 | — |
| 0 (this device) | K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb… | Fisher & Paykel Healthcare, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 CBK? 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K203449 | F&P Visairo NIV Mask RangeSummary page 5…Use Regulatory Class Class II (21 CFR §868.5895) Product Code CBK III. PREDICATE DEVICE Predicate device: F&P Visairo NIV Mask, K203449 Reference device: F&P Nivairo Mask, K191624 Page 1 of 5 IV. DEVICE… | 2021 |
| † | K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | 2020 |
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 24 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 13 ancestors have a recall of any class.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Fisher & Paykel Healthcare single-patient use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained, by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252173: F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252173
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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