510(k) · Cleared
ClearedThe iNAP One Sleep Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somnics, Inc. · OZR Intraoral Pressure Gradient Device
Cleared on Jun 16, 2023 as substantially equivalent to K193460 (Somnice, Inc., 2020) after a 444-day review. Its family tree reaches back 13 generations to 1996.
- Decided
- Jun 16, 2023
- Review
- 444 days
- Class
- Class II
- Product code
- OZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K953930 (1996). 124 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet.
- Root · 13 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 9 generations between
- 3 generations backK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
- 2 generations backK130538 Winx Sleep Therapy SystemApnicure, Inc. · 2013
- 1 generation backK193460 The iNAP One Sleep Therapy SystemSomnice, Inc. · 2020
- This deviceK220907 The iNAP One Sleep Therapy SystemSomnics, Inc. · 2023
Show all 13 generations
- Root · 13 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 12 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 11 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 10 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 9 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 8 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 7 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 6 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 5 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 4 generations backK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- 3 generations backK122130 Winx Sleep Therapy SystemApnicure, Inc. · 2012
- 2 generations backK130538 Winx Sleep Therapy SystemApnicure, Inc. · 2013
- 1 generation backK193460 The iNAP One Sleep Therapy SystemSomnice, Inc. · 2020
- This deviceK220907 The iNAP One Sleep Therapy SystemSomnics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −12 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −11 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −10 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −9 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −8 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −7 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −6 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −5 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| −4 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
| −3 | K122130 | Winx Sleep Therapy System | Apnicure, Inc. | 2012 | — |
| −2 | K130538 | Winx Sleep Therapy System | Apnicure, Inc. | 2013 | — |
| −1 | K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | 2020 | — |
| 0 (this device) | K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 12 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 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 OZR? 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 OZR device
- #1 K193460 The iNAP One Sleep Therapy Systemscore 5.7 · 12 generations · no Class I recall
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 |
|---|---|---|---|
| * | K193460 | The iNAP One Sleep Therapy SystemSummary page 4…Product Code: OZR 3. Predicate Device Trade Name: The iNAP One Sleep Therapy System Manufacturer: Somnics, Inc. 510(k)#: K193460 4. Indications for Use: The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sle… | 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 27 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 19 of the 124 ancestors have a recall of any class.
How does its category compare?
All OZR devicesOZR Intraoral Pressure Gradient Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OZR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OZR
Too few OZR 510(k)s in any year since 2007 to give a median.
Recalls per year · OZR
No recall names OZR since 2007.
Adverse event reports per year · OZR
1in 2017
MAUDE reports naming product code OZR, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220907: The iNAP One Sleep Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220907
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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