510(k) · Cleared
ClearedO_Two Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O-Two Medical Technologies, Inc. · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Dec 27, 2011 as substantially equivalent to K093862 (O-Two Medical Technologies, Inc., 2010) and 1 other predicate after a 117-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Dec 27, 2011
- Review
- 117 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K862830 (1986). 16 ancestors in all, the oldest K801883 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK862830 Models 2R and 3R Pneupac Ventilator/ResuscitatorPneupac, Ltd. · 1986
- 4 generations backK024344 Pneuton VentilatorAiron Corporation · 2003
- 3 generations backK043085 Modification to: Pneuton VentilatorAiron Corporation · 2004
- 2 generations backK080692 Macs Cpap SystemAiron Corporation · 2008
- 1 generation backK093862 Carevent Handheld Cpap SystemO-Two Medical Technologies, Inc. · 2010
- This deviceK112546 O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862830 | Models 2R and 3R Pneupac Ventilator/Resuscitator | Pneupac, Ltd. | 1986 | — |
| −4 | K024344 | Pneuton Ventilator | Airon Corporation | 2003 | — |
| −3 | K043085 | Modification to: Pneuton Ventilator | Airon Corporation | 2004 | — |
| −2 | K080692 | Macs Cpap System | Airon Corporation | 2008 | — |
| −1 | K093862 | Carevent Handheld Cpap System | O-Two Medical Technologies, Inc. | 2010 | — |
| 0 (this device) | K112546 | O_Two Cpap System | O-Two Medical Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 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 BYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K093862 | Carevent Handheld Cpap SystemSummary page 1…CAREvent Handheld CPAP System " Manufactured by 0-Two Medical Technologies Inc. " 510(k) number K093862 Boussignac CPAP Device * Manufactured by Vygon S. A.… | 2010 |
| * | K013884 | Boussignac C.P.a.P. DeviceSummary page 1…862 Boussignac CPAP Device * Manufactured by Vygon S. A. " 510(k) number K013884 Device Description: The o-two OPAP device provides a constant positive airway pressure to the lungs of patients in respiratory… | 2003 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All BYE devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BYE
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · BYE
117in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYE
1in 2015
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BYE
7in 2025
MAUDE reports naming product code BYE, 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 | 1 | — | 4 | 8 |
| 2008 | 1 | — | 2 | 3 |
| 2009 | 3 | 155 | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
o-two OPAP System is intended to provide a constant positive airway pressure to spontaneously breathing patients in the hospital environment and emergency medical service applications to treat patients in respiratory distress.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112546 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112546: O_Two Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112546
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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