510(k) · Cleared
ClearedModified Sanders BI-Papeasy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Dec 8, 1988 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 of the 90 devices in its family, counting itself, have a Class I recall. 89 later devices descend from it.
- Decided
- Dec 8, 1988
- Review
- 90 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 0
89 later devices descend from it, 5 citing it directly. 14 of the 90 devices in this family, counting this one, have a Class I recall.
- This deviceK883825 Modified Sanders BI-PapeasyRespironics, Inc. · 1988
- Descendant · cites it directly · 85 of its ownK951264 Bipap Model S/T-DRespironics, Inc. · 1996
- Descendant · 2 generations on · 58 of its ownK991648 Reusable Contour II Nasal MaskRespironics, Inc. · 1999
- Descendant · cites it directly · 44 of its ownK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
- Descendant · 2 generations on · 42 of its ownK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
- Descendant · 3 generations on · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 89 · See all- K951264Bipap Model S/T-DRespironics, Inc. · 1996 · cites it directly85descendants
- K991648Reusable Contour II Nasal MaskRespironics, Inc. · 1999 · 2 generations on58descendants
- K955324Bipap S/T-D 30 SystemRespironics, Inc. · 1996 · cites it directly44descendants
- K982454Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · 2 generations on42descendants
- K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883825 | Modified Sanders BI-Papeasy | Respironics, Inc. | 1988 | — |
| +1 | K951264 | Bipap Model S/T-D | Respironics, Inc. | 1996 | — |
| +2 | K991648 | Reusable Contour II Nasal Mask | Respironics, Inc. | 1999 | — |
| +1 | K955324 | Bipap S/T-D 30 System | Respironics, Inc. | 1996 | — |
| +2 | K982454 | Bipap Vision Ventilatory Support | Respironics, Inc. | 1998 | 2 |
| +3 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2002 | 2 | 1 |
| 2004 | 3 | 1 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 1 |
| 2008 | 3 | 1 |
| 2009 | 6 | 1 |
| 2010 | 5 | 1 |
| 2011 | 10 | 3 |
| 2012 | 8 | 2 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 1 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2020 | 3 | 0 |
| 2021 | 3 | 1 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
14 devices in this family have a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (89)
See all 895 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (14 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · 3 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 4 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K102985V60 Ventilator with PPV and Auto-Trak+ Software OptionsRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 18 Class I recalls
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- Of its descendants, K951264 (Respironics, Inc., 1996) has gone furthest, with 85 descendants of its own.
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.
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) | — |
https://510kreport.com/device/K883825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883825: Modified Sanders BI-Papeasy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883825
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026