510(k) · Cleared
ClearedPuritan Bennett, Sandman Duo and Sandman Duo ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Developpement France · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 9, 2008 as substantially equivalent to K071575 (Mallinckrodt Developpement France, 2007) and 3 other predicates after a 63-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Oct 9, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K903764 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 6 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 5 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 4 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 3 generations backK020886 Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett…Tyco Healthcare Nancy · 2002
- 2 generations backK041819 Goodknight 425, Modelm-114500-00Mallinckrodt Developpement France · 2004
- 1 generation backK050072 Goodknight 425STNellcor Puritan Bennett, Inc. · 2005
- This deviceK082237 Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −6 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −5 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −4 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −3 | K020886 | Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett… | Tyco Healthcare Nancy | 2002 | — |
| −2 | K041819 | Goodknight 425, Modelm-114500-00 | Mallinckrodt Developpement France | 2004 | — |
| −1 | K050072 | Goodknight 425ST | Nellcor Puritan Bennett, Inc. | 2005 | — |
| 0 (this device) | K082237 | Puritan Bennett, Sandman Duo and Sandman Duo ST | Mallinckrodt Developpement France | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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? (4)
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 |
|---|---|---|---|
| * | K071575 | Sandman IntroSummary page 1…red with optional humidification. Predicate Device Equivalence The Sandman Duo and the Sandman Duo ST are equivalent to the Puritan Bennett Sandman Intro (K071 575) for all aspects except the Bilevel mode, to the Puritan Bennett Sandman Info (K080439) only for detection of apneas and hypop… | 2007 |
| * | K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…Summary page 1…uo and the Sandman Duo ST are equivalent to the Puritan Bennett Sandman Intro (K071 575) for all aspects except the Bilevel mode, to the Puritan Bennett Sandman Info (K080439) only for detection of apneas and hypopneas, the Puritan Bennett GoodlKnight 425 (K041819) for the Bilevel mode. The Sandma… | 2008 |
| * | K041819 | Goodknight 425, Modelm-114500-00Summary page 1…or all aspects except the Bilevel mode, to the Puritan Bennett Sandman Info (K080439) only for detection of apneas and hypopneas, the Puritan Bennett GoodlKnight 425 (K041819) for the Bilevel mode. The Sandman Duo ST is equivalent to the Puritan Bennett GoodlKnight 425 ST (K050072) for the Bilevel… | 2004 |
| * | K050072 | Goodknight 425STSummary page 1…neas and hypopneas, the Puritan Bennett GoodlKnight 425 (K041819) for the Bilevel mode. The Sandman Duo ST is equivalent to the Puritan Bennett GoodlKnight 425 ST (K050072) for the Bilevel mode including optional backup frequency. Covidien PROPRIETARY & CONFIDENTIAL… | 2005 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Sandman Duo and Sandman Duo ST are indicated for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 30kg (661b) within homecare and hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082237 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082237: Puritan Bennett, Sandman Duo and Sandman Duo ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082237
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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