510(k) · Cleared
ClearedMallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett France Dvpt. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Mar 7, 2000 as substantially equivalent to K991150 (Nellcor Puritan Bennett France Dvpt., 1999) after a 137-day review. Its family tree reaches back 4 generations to 1990. 22 later devices descend from it.
- Decided
- Mar 7, 2000
- Review
- 137 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903764 (1990). 7 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 3 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 2 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 1 generation backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- This deviceK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- Descendant · cites it directly · 20 of its ownK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK063476 Breas Isleep 20IBreas Medical AB · 2007
- Descendant · 3 generations on · 10 of its ownK071560 Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK042945 Aura Cpap SystemAeiomed, Inc. · 2005
- Descendant · 4 generations on · 5 of its ownK111549 Attune Sleep Apnea SystemApnicure, Inc. · 2012
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K030985Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003 · cites it directly20descendants
- K063476Breas Isleep 20IBreas Medical AB · 2007 · 2 generations on12descendants
- K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008 · 3 generations on10descendants
- K042945Aura Cpap SystemAeiomed, Inc. · 2005 · 2 generations on6descendants
- K111549Attune Sleep Apnea SystemApnicure, Inc. · 2012 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −3 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −2 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −1 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| 0 (this device) | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| +1 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
| +2 | K063476 | Breas Isleep 20I | Breas Medical AB | 2007 | — |
| +3 | K071560 | Provent Nasal Dilator, Model BR2 | Ventus Medical, Inc. | 2008 | — |
| +2 | K042945 | Aura Cpap System | Aeiomed, Inc. | 2005 | — |
| +4 | K111549 | Attune Sleep Apnea System | Apnicure, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 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), 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 BZD? 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 BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K991150 | Nellcor Puritan Bennett, Goodknight 418GSummary page 1…dicate Device Equivalence We are claiming substantial equivalence to the Nellcor Puritan Bennett GoodKnight 418G CPAP device, cleared for commercial distribution as per K991150. 4.0 - Device Description The GoodKnight 418 Series Devices consist of the following elements: - GoodKnight 418 A (GK418A) C-PA… | 1999 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K030985 (Vital Signs, Inc., 2003) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K991150.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The Mallinckrodt GoodKnight 418 Series is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993584: Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993584
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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