510(k) · Cleared
ClearedUtopia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respcare, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Dec 7, 2005 as substantially equivalent to K030822 (Hans Rudolph, Inc., 2003) and 2 other predicates after a 111-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Dec 7, 2005
- Review
- 111 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K936047 (1995). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK936047 Spectrum (TM) MaskRespironics, Inc. · 1995
- 3 generations backK961915 Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, LargeRespironics, Inc. · 1996
- 2 generations backK020759 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large…Hans Rudolph, Inc. · 2002
- 1 generation backK030822 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV MasksHans Rudolph, Inc. · 2003
- This deviceK052249 UtopiaRespcare, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K936047 | Spectrum (TM) Mask | Respironics, Inc. | 1995 | — |
| −3 | K961915 | Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large | Respironics, Inc. | 1996 | — |
| −2 | K020759 | 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630… | Hans Rudolph, Inc. | 2002 | — |
| −1 | K030822 | 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV Masks | Hans Rudolph, Inc. | 2003 | — |
| 0 (this device) | K052249 | Utopia | Respcare, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K030822 | 7600 Series Multi-Patient Multi-Use Oro-Nasal Cpap/NPPV MasksSummary page 1…Class II, CFR 868.5905, BZD Classification Name: Accessory to Noncontinuous Ventilator Predicate Devices: K030822 - Hans Rudolph 7600 Vmask K040506 - Fisher & Paykel HC431… | 2003 |
| * | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431ASummary page 1…Accessory to Noncontinuous Ventilator Predicate Devices: K030822 - Hans Rudolph 7600 Vmask K040506 - Fisher & Paykel HC431 K002465 - Respironics PerformaTrak Device Description The Utopi… | 2004 |
| * | K002465 | Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876Summary page 1…K030822 - Hans Rudolph 7600 Vmask K040506 - Fisher & Paykel HC431 K002465 - Respironics PerformaTrak Device Description The Utopia is a patient interface accessory to a positive pressure ventilator inten… | 2000 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K030822.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Utopia is intended for use by adults (>30 kg) as a patient interface for currently-marketed CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea.
(Applies to the standard version):
For homecare applications, the Utopia may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the Disposable version):
The Utopia Disposable is a single patient, single use interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052249: Utopia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052249
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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