510(k) · Cleared
ClearedBreathex Omega Cpap Device, Model 322
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hoffman Laboratories, LLC · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Dec 16, 2005 as substantially equivalent to K973161 (Fisher & Paykel Electronics, Ltd., 1998) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.
- Decided
- Dec 16, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K952292 (1995). 7 ancestors in all, the oldest K915460 (1993). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 2 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 1 generation backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- This deviceK052597 Breathex Omega Cpap Device, Model 322Hoffman Laboratories, LLC · 2005
- Descendant · cites it directly · 5 of its ownK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK132127 Transcend AutoSomnetics International, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK121374 ZI BlowerDeshum Medical · 2013
- Descendant · 3 generations on · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK150365 Cloud9 SystemInsleep Technologies, LLC · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010 · cites it directly5descendants
- K132127Transcend AutoSomnetics International, Inc. · 2013 · 2 generations on1descendant
- K121374ZI BlowerDeshum Medical · 2013 · cites it directly1descendant
- K180388Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018 · 3 generations on0descendants
- K150365Cloud9 SystemInsleep Technologies, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −2 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −1 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| 0 (this device) | K052597 | Breathex Omega Cpap Device, Model 322 | Hoffman Laboratories, LLC | 2005 | — |
| +1 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| +2 | K132127 | Transcend Auto | Somnetics International, Inc. | 2013 | — |
| +1 | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| +3 | K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018 | — |
| +2 | K150365 | Cloud9 System | Insleep Technologies, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K973161 | Cpap Humidifier (HC 200)Summary page 1…Classification/Name: Ventilator, non-continuous, non-life supporting Product Code(s): 21 CUR 868.5903 132D Class: Class H1 Predicate Device(s): * 510K Number: K973161 * Manufacturer: Fisher & Pavkel H-ealthcare * Trade Name: HC200 CPAP * 510K Number: K99087i * Manufactur… | 1998 |
| * | K990871 | Pillowpositive Cervical Pillow | 1999 |
What descends from it? (7)
3 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 10 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K100121 (Aeiomed, Inc., 2010) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K973161.
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 BreatheX Omega CPAP device is intended for treatment of obstructive sleep apnea
(OSA) in spontaneously breathing adults weighing at least 30 kg.
The BreatheX Omega CPAP device provides continuous positive airway pressure.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052597: Breathex Omega Cpap Device, Model 322.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052597
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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