510(k) · Cleared
ClearedPurtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett, Goodknight 420S Model M-113903-US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare Nancy · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Nov 1, 2002 as substantially equivalent to K991150 (Nellcor Puritan Bennett France Dvpt., 1999) after a 228-day review. Its family tree reaches back 4 generations to 1990. 5 later devices descend from it.
- Decided
- Nov 1, 2002
- Review
- 228 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. 5 later devices descend from it, 3 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 deviceK020886 Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett…Tyco Healthcare Nancy · 2002
- Descendant · cites it directly · 2 of its ownK041819 Goodknight 425, Modelm-114500-00Mallinckrodt Developpement France · 2004
- Descendant · cites it directly · 1 of its ownK080439 Sandman Info Without Humidifier/ Sandman Auto Without Humidifier…Mallinckrodt Developpement France · 2008
- Descendant · 2 generations on · 1 of its ownK050072 Goodknight 425STNellcor Puritan Bennett, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK082237 Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008
- Descendant · cites it directly · 0 of its ownK031470 Puritan Bennett, Goodknight 420 Evolution, Model M-113903-USTyco Healthcare Nancy · 2003
Most influential descendants
Showing 5 of 5 · See all- K041819Goodknight 425, Modelm-114500-00Mallinckrodt Developpement France · 2004 · cites it directly2descendants
- K080439Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…Mallinckrodt Developpement France · 2008 · cites it directly1descendant
- K050072Goodknight 425STNellcor Puritan Bennett, Inc. · 2005 · 2 generations on1descendant
- K082237Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008 · 2 generations on0descendants
- K031470Puritan Bennett, Goodknight 420 Evolution, Model M-113903-USTyco Healthcare Nancy · 2003 · cites it directly0descendants
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) | K020886 | Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett… | Tyco Healthcare Nancy | 2002 | — |
| +1 | K041819 | Goodknight 425, Modelm-114500-00 | Mallinckrodt Developpement France | 2004 | — |
| +1 | K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model… | Mallinckrodt Developpement France | 2008 | — |
| +2 | K050072 | Goodknight 425ST | Nellcor Puritan Bennett, Inc. | 2005 | — |
| +2 | K082237 | Puritan Bennett, Sandman Duo and Sandman Duo ST | Mallinckrodt Developpement France | 2008 | — |
| +1 | K031470 | Puritan Bennett, Goodknight 420 Evolution, Model M-113903-US | Tyco Healthcare Nancy | 2003 | — |
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 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 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….0 - Predicate Device Equivalence We are claiming substantial equivalence to the Puritan Bennett GoodKnight 418G CPAP device, cleared for commercial distribution as per K991150. 4.0 - Device Description The GoodKnight 420 Series Devices consist of the following elements: - GoodKnight 420G (CK… | 1999 |
What descends from it? (5)
3 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 12 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K041819 (Mallinckrodt Developpement France, 2004) has gone furthest, with 2 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 Puritan Bennett GoodKnight 420 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 as stated in the FDA summary.
https://510kreport.com/device/K020886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020886: Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett, Goodknight 420S Model M-113903-US.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020886
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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