510(k) · Cleared
ClearedGoodknight H20, Model M-114600-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Developpement France · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Jan 10, 2005 as substantially equivalent to K030090 (Respironics, Inc., 2003) after a 151-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Jan 10, 2005
- Review
- 151 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915460 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK915460 Heated Respiratory Humidifier HC100Fisher & Paykel Electronics, Ltd. · 1993
- 2 generations backK012633 Respironics Heated HumidifierRespironics, Inc. · 2002
- 1 generation backK030090 H2 Heated HumidifierRespironics, Inc. · 2003
- This deviceK042184 Goodknight H20, Model M-114600-00Mallinckrodt Developpement France · 2005
- Descendant · cites it directly · 1 of its ownK080439 Sandman Info Without Humidifier/ Sandman Auto Without Humidifier…Mallinckrodt Developpement France · 2008
- Descendant · 2 generations on · 0 of its ownK082237 Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915460 | Heated Respiratory Humidifier HC100 | Fisher & Paykel Electronics, Ltd. | 1993 | — |
| −2 | K012633 | Respironics Heated Humidifier | Respironics, Inc. | 2002 | — |
| −1 | K030090 | H2 Heated Humidifier | Respironics, Inc. | 2003 | — |
| 0 (this device) | K042184 | Goodknight H20, Model M-114600-00 | Mallinckrodt Developpement France | 2005 | — |
| +1 | K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model… | Mallinckrodt Developpement France | 2008 | — |
| +2 | K082237 | Puritan Bennett, Sandman Duo and Sandman Duo ST | Mallinckrodt Developpement France | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 BTT? 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 BTT device
- #1 K222197 F&P Optiflow Junior 2/2+ Nasal Cannula…score 16.8 · 10 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 |
|---|---|---|---|
| * | K030090 | H2 Heated HumidifierSummary page 1…ntial equivalence to the Respironics H2 Heated Humidifier, cleared for commercial distribution per K(030090. 4.0 - Indications for Use The Puritan Bennett GoodKnight H20 is an accessory intended to warm… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model… | 2008 | 1 |
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 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080439 (Mallinckrodt Developpement France, 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BTT devicesBTT Humidifier, Respiratory Gas, (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTT
104in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTT
1in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · BTT
1,743in 2025
MAUDE reports naming product code BTT, 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 | 6 | 73 | 1 | 365 |
| 2008 | 4 | 199 | 1 | 456 |
| 2009 | 1 | — | 0 | 558 |
| 2010 | 4 | 113 | 2 | 562 |
| 2011 | 3 | 116 | 1 | 665 |
| 2012 | 2 | — | 0 | 583 |
| 2013 | 6 | 171 | 0 | 718 |
| 2014 | 7 | 231 | 5 (4) | 718 |
| 2015 | 1 | — | 0 | 670 |
| 2016 | 3 | 157 | 0 | 1,094 |
| 2017 | 3 | 303 | 0 | 1,007 |
| 2018 | 2 | — | 0 | 918 |
| 2019 | 1 | — | 0 | 894 |
| 2020 | 2 | — | 0 | 1,188 |
| 2021 | 2 | — | 0 | 1,510 |
| 2022 | 3 | 290 | 0 | 749 |
| 2023 | 7 | 258 | 0 | 716 |
| 2024 | 7 | 219 | 0 | 501 |
| 2025 | 4 | 104 | 1 | 1,743 |
| 2026 | 4 | 184 | 1 | — |
What is it indicated for?
The Puritan Bennett GoodKnight H20 is an accessory intended to warm and add moisture to the inspiratory gas flow for administration to a patient undergoing CPAP or bi-level therapy.
It is intended for use with adult patients receiving CPAP or Bi-level therapy for the treatment of Obstructive Sleep Apnea in the homecare and hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042184: Goodknight H20, Model M-114600-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042184
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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