510(k) · Cleared
ClearedCompanion 318 Nasal Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Sep 10, 1990 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.
- Decided
- Sep 10, 1990
- Review
- 21 days
- Class
- Class II
- Product code
- BYE
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly.
- This deviceK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- Descendant · cites it directly · 30 of its ownK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- Descendant · 2 generations on · 29 of its ownK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- Descendant · 3 generations on · 28 of its ownK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- Descendant · 4 generations on · 22 of its ownK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- Descendant · 5 generations on · 20 of its ownK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K960518The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996 · cites it directly30descendants
- K980365Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998 · 2 generations on29descendants
- K991150Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999 · 3 generations on28descendants
- K993584Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000 · 4 generations on22descendants
- K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| +1 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| +2 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| +3 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| +4 | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| +5 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | 1996 | 30 |
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?
- Of its descendants, K960518 (Puritan Bennett Corp., 1996) has gone furthest, with 30 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/K903764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K903764: Companion 318 Nasal Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903764
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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