510(k) · Cleared
ClearedWinx Sleep Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apnicure, Inc. · OZR Intraoral Pressure Gradient Device
Cleared on Jun 13, 2014 as substantially equivalent to K111549 (Apnicure, Inc., 2012) after a 347-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jun 13, 2014
- Review
- 347 days
- Class
- Class II
- Product code
- OZR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K953930 (1996). 121 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 6 generations between
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 1 generation backK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- This deviceK132003 Winx Sleep Therapy SystemApnicure, Inc. · 2014
Show all 10 generations
- Root · 10 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 9 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 8 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 7 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 6 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 5 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 4 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 3 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 2 generations backK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- 1 generation backK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
- This deviceK132003 Winx Sleep Therapy SystemApnicure, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −9 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −8 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −7 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −6 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −5 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −4 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −3 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −2 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| −1 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
| 0 (this device) | K132003 | Winx Sleep Therapy System | Apnicure, Inc. | 2014 | — |
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 K220907 The iNAP One Sleep Therapy Systemscore 9.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K111549 | Attune Sleep Apnea SystemSummary page 2…-Manufacturer §61 0(k)# Winx Sleep Therapy System ApniCure K1 11549 Technological Characteristics: Characteristic <-.Winx Sleep--Therapy, Systerif K- Winx+… | 2012 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 19 of the 121 ancestors have a recall of any class.
- 2 other devices also cite its predicate K111549.
How does its category compare?
All OZR devicesOZR Intraoral Pressure Gradient Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132003 · printed Nov 3, 2026
Cite this page
510(k) Report. “K132003: Winx Sleep Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K132003
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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