510(k) · Cleared
ClearedDevilbiss Model 9200D Heated Humidifier System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical Hhg, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Jun 3, 2002 after a 75-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 3, 2002
- Review
- 75 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK020900 Devilbiss Model 9200D Heated Humidifier SystemSunrise Medical Hhg, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK040507 Taga Velocity Passover Humidifier with Heater, Model TM1000HTaga Medical Technologies, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040507Taga Velocity Passover Humidifier with Heater, Model TM1000HTaga Medical Technologies, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020900 | Devilbiss Model 9200D Heated Humidifier System | Sunrise Medical Hhg, Inc. | 2002 | — |
| +1 | K040507 | Taga Velocity Passover Humidifier with Heater, Model TM1000H | Taga Medical Technologies, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K040507 | Taga Velocity Passover Humidifier with Heater, Model TM1000H | 2004 | 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?
- Of its descendants, K040507 (Taga Medical Technologies, Inc., 2004) has gone furthest, with 0 descendants 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 DeVilbiss Heated Humidifier System, consisting of the 9 1OOD DeVilbiss CPAP Humidifier and the 9200 DeVilbiss Humidifier Heater, is to be used in conjunction with most positive airway pressure devices that require humidity to be added to the circuitry. The DeVilbiss Heated Humidifier System is not intended to be used with auto-adjusting CPAP devices unless the labeling for the CPAP machine states that the CPAP machine will function in autoset mode…
Read the full statement (161 words)
The DeVilbiss Heated Humidifier System, consisting of the 9 1OOD DeVilbiss CPAP Humidifier and the 9200 DeVilbiss Humidifier Heater, is to be used in conjunction with most positive airway pressure devices that require humidity to be added to the circuitry.
The DeVilbiss Heated Humidifier System is not intended to be used with auto-adjusting CPAP devices unless the labeling for the CPAP machine states that the CPAP machine will function in autoset mode when used with the 9200 heated humidifier system. The heated humidifier system may adversely affect the operation of certain CPAP machines that have automated pressure setting.
The DeVilbiss Heated Humidifier System is for use in the home environment and is to be used only on the order of a physician. The humidifier can be used with CPAP and Bilevel devices, which have a maximum operating pressure of 20 cm H20. The humidifier can also be used with noninvasive ventilation devices that have a maximum operating pressure of 40 cmHzO.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K020900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020900: Devilbiss Model 9200D Heated Humidifier System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020900
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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