510(k) · Cleared
ClearedAcute Care Face Mask, Model RT040
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Apr 6, 2006 as substantially equivalent to K040506 (Fisher & Paykel Healthcare, Ltd., 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 2001. 7 later devices descend from it.
- Decided
- Apr 6, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003894 (2001). 9 ancestors in all, the oldest K982530 (1998). 7 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK003894 Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2001 · Recalled
- 3 generations backK023559 Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003
- 2 generations backK033087 Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- 1 generation backK040506 Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- This deviceK060044 Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK083122 Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd. · 2009
- Descendant · 2 generations on · 2 of its ownK173060 F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard…Fisher and Paykel Healthcare Limited · 2018
- Descendant · 3 generations on · 1 of its ownK203449 F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK170367 Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation…Fisher and Paykel Healthcare Limited · 2017
- Descendant · 4 generations on · 0 of its ownK252173 F&P OptiNIV Hospital Vented Full Face Mask Compatible with…Fisher & Paykel Healthcare, Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K083122Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd. · 2009 · cites it directly4descendants
- K173060F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow VersionFisher and Paykel Healthcare Limited · 2018 · 2 generations on2descendants
- K203449F&P Visairo NIV Mask RangeFisher & Paykel Healthcare, Ltd. · 2021 · 3 generations on1descendant
- K170367Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large…Fisher and Paykel Healthcare Limited · 2017 · cites it directly1descendant
- K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A…Fisher & Paykel Healthcare, Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2001 | 6 |
| −3 | K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −2 | K033087 | Oracle Oral Mask, Model HC451A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| −1 | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| 0 (this device) | K060044 | Acute Care Face Mask, Model RT040 | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| +1 | 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 | — |
| +3 | K203449 | F&P Visairo NIV Mask Range | Fisher & Paykel Healthcare, Ltd. | 2021 | — |
| +1 | K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve -… | Fisher and Paykel Healthcare Limited | 2017 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 MNT? 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 MNT device
- #1 K233643 F&P Airvo 3 NIV (PT311US)score 13.5 · 10 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 |
|---|---|---|---|
| * | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431ASummary page 1…uous, Minimal ventilatory support, Facility use (accessory to) (21 CFR § 868.5895, product code MNT) Predicate device K040506 Fisher & Paykel Healthcare Flexifit HC431 Face Mask K023135 Respironics Image3 SE Disposable Face Mas… | 2004 |
| * | K023135 | IMAGE3 SE Disposable Full Face MaskSummary page 1…(21 CFR § 868.5895, product code MNT) Predicate device K040506 Fisher & Paykel Healthcare Flexifit HC431 Face Mask K023135 Respironics Image3 SE Disposable Face Mask Fisher &Paykel Healthcare Acute Care Face Mask… | 2003 |
What descends from it? (7)
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 5 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K083122 (Fisher & Paykel Healthcare, Ltd., 2009) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K040506.
How does its category compare?
All MNT devicesMNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNT
Too few MNT 510(k)s in any year since 2007 to give a median.
Recalls per year · MNT
5in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 2025
MAUDE reports naming product code MNT, 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 | 0 | — | 1 | 59 |
| 2008 | 1 | — | 0 | 76 |
| 2009 | 2 | — | 1 | 29 |
| 2010 | 0 | — | 1 | 63 |
| 2011 | 2 | — | 0 | 170 |
| 2012 | 2 | — | 0 | 257 |
| 2013 | 1 | — | 0 | 322 |
| 2014 | 0 | — | 0 | 887 |
| 2015 | 0 | — | 0 | 1,657 |
| 2016 | 0 | — | 0 | 2,515 |
| 2017 | 1 | — | 0 | 2,878 |
| 2018 | 0 | — | 0 | 2,203 |
| 2019 | 0 | — | 1 (1) | 9,350 |
| 2020 | 1 | — | 33 | 4,170 |
| 2021 | 0 | — | 0 | 3,790 |
| 2022 | 1 | — | 5 (5) | 3,277 |
| 2023 | 1 | — | 0 | 4,565 |
| 2024 | 2 | — | 0 | 4,808 |
| 2025 | 1 | — | 0 | 3,545 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Fisher & Paykel Healthcare Acute Care Single Use Face Mask is a nasal-oral patient
interface for use as an accessory to ventilators providing noninvasive bi-level and constant
positive airway pressure ventilation. The ventilator must have adequate alarms and safety
systems for ventilator failure. 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 the hospital/institutional environments only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060044: Acute Care Face Mask, Model RT040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060044
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