510(k) · Cleared
ClearedSandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model M-114801-114802-US; Sandman Info with Intergrate
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 May 16, 2008 as substantially equivalent to K020886 (Tyco Healthcare Nancy, 2002) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- May 16, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903764 (1990). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 4 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 3 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 2 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 1 generation backK020886 Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett…Tyco Healthcare Nancy · 2002
- This deviceK080439 Sandman Info Without Humidifier/ Sandman Auto Without Humidifier…Mallinckrodt Developpement France · 2008
- Descendant · cites it directly · 0 of its ownK082237 Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008
Most influential descendants
Showing 1 of 1 · See all- K082237Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −4 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −3 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −2 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −1 | K020886 | Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett… | Tyco Healthcare Nancy | 2002 | — |
| 0 (this device) | K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model… | Mallinckrodt Developpement France | 2008 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K020886 | Purtian Bennett, Good Knight 420G Model M-113900-US; Purtan Bennett, Goodknight 420S…Summary page 3…= Page 3 === Predicate Device Equivalence The Puritan Bennett Sandman Info is equivalent to the Puritan Bennett GoodKnight 420S CPAP device (K020886), with the optional additive functionality of the Puritan Bennett GoodKnight H20 heated humidifier (K042184).… | 2002 |
| * | K042184 | Goodknight H20, Model M-114600-00Summary page 3…uritan Bennett GoodKnight 420S CPAP device (K020886), with the optional additive functionality of the Puritan Bennett GoodKnight H20 heated humidifier (K042184). The Puritan Bennett Sandman Auto is equivalent to the Puritan Bennett GoodKnight 420E CPAP device (K020886),… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082237 | Puritan Bennett, Sandman Duo and Sandman Duo ST | 2008 | 0 |
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 3.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K082237 (Mallinckrodt Developpement France, 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K020886.
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 Info, and Sandman Auto 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/K080439 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080439: Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model M-114801-114802-US; Sandman Info with Intergrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080439
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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