510(k) · Cleared
ClearedHospital Full Face Mask Non Vented, Model: RT041
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 Mar 4, 2009 as substantially equivalent to K060044 (Fisher & Paykel Healthcare, Ltd., 2006) and 1 other predicate after a 133-day review. Its family tree reaches back 5 generations to 2001. 4 later devices descend from it.
- Decided
- Mar 4, 2009
- Review
- 133 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003894 (2001). 10 ancestors in all, the oldest K982530 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK003894 Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2001 · Recalled
- 4 generations backK023559 Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003
- 3 generations backK033087 Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- 2 generations backK040506 Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- 1 generation backK060044 Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd. · 2006
- This deviceK083122 Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK173060 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard…Fisher and Paykel Healthcare Limited · 2018
- Descendant · 2 generations on · 1 of its ownK203449 F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK252173 F&P OptiNIV Hospital Vented Full Face Mask Compatible with…Fisher & Paykel Healthcare, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK102120 Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone…Hsiner Co., Ltd. · 2011
Most influential descendants
Showing 4 of 4 · See all- K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited · 2018 · cites it directly2descendants
- K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd. · 2021 · 2 generations on1descendant
- K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd. · 2025 · 3 generations on0descendants
- K102120Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model…Hsiner Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2001 | 6 |
| −4 | K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −3 | K033087 | Oracle Oral Mask, Model HC451A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| −2 | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| −1 | K060044 | Acute Care Face Mask, Model RT040 | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| 0 (this device) | K083122 | Hospital Full Face Mask Non Vented, Model: RT041 | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| +1 | K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | Fisher and Paykel Healthcare Limited | 2018 | — |
| +2 | K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | 2021 | — |
| +3 | K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb… | Fisher & Paykel Healthcare, Ltd. | 2025 | — |
| +1 | K102120 | Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask… | Hsiner Co., Ltd. | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060044 | Acute Care Face Mask, Model RT040Summary page 1…Classification name Continuous ventilator (accessory to) Class 11 (21 CFR § 868.5895), product code CBK Predicate device K060044 Fisher & Paykel Healthcare RT040 Acute Care Face Mask 2 K023135 Respironics Image3 SE Disposable Face… | 2006 |
| * | K023135 | IMAGE3 SE Disposable Full Face MaskSummary page 1…Class 11 (21 CFR § 868.5895), product code CBK Predicate device K060044 Fisher & Paykel Healthcare RT040 Acute Care Face Mask 2 K023135 Respironics Image3 SE Disposable Face Mask 3 (PerformaTrakSE) 1 Referred to throughout this documen… | 2003 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K173060 (Fisher and Paykel Healthcare Limited, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K060044.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 RT041 Hospital Full Face Mask Non Vented is a patient interface for use as an accessory to a respiratory therapy device, i.e. ventilator that has adequate alarms and safety systems for ventilator failure, providing noninvasive positive pressure respiratory therapy. The mask is for single patient use with spontaneously breathing adult (> 30 kg) patients with respiratory insufficiency or respiratory failure who are suitable for noninvasive pressure support ventilation in hospital/institutional environments only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083122: Hospital Full Face Mask Non Vented, Model: RT041.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083122
Report an extraction error
Are you the manufacturer?
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