510(k) · Cleared
ClearedMarquest SCT 3000, Heated Humidification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquest Medical Products, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Oct 11, 1990 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 11, 1990
- Review
- 86 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK903138 Marquest SCT 3000, Heated Humidification SystemMarquest Medical Products, Inc. · 1990
- Descendant · cites it directly · 1 of its ownK962220 Heated Wire Circuits for SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK993282 Ipi Humidifier ChamberI.P.I. Medical Products · 2000
- Descendant · 2 generations on · 0 of its ownK993268 Mallinckrodt Dar Heated Wire Breathing CircuitMallinckrodt Dar S.R.L. · 2000
- Descendant · cites it directly · 0 of its ownK970478 SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997
Most influential descendants
Showing 4 of 4 · See all- K962220Heated Wire Circuits for SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997 · cites it directly1descendant
- K993282Ipi Humidifier ChamberI.P.I. Medical Products · 2000 · cites it directly0descendants
- K993268Mallinckrodt Dar Heated Wire Breathing CircuitMallinckrodt Dar S.R.L. · 2000 · 2 generations on0descendants
- K970478SCT 3000 Heated HumidifierMarquest Medical Products, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903138 | Marquest SCT 3000, Heated Humidification System | Marquest Medical Products, Inc. | 1990 | — |
| +1 | K962220 | Heated Wire Circuits for SCT 3000 Heated Humidifier | Marquest Medical Products, Inc. | 1997 | — |
| +1 | K993282 | Ipi Humidifier Chamber | I.P.I. Medical Products | 2000 | — |
| +2 | K993268 | Mallinckrodt Dar Heated Wire Breathing Circuit | Mallinckrodt Dar S.R.L. | 2000 | — |
| +1 | K970478 | SCT 3000 Heated Humidifier | Marquest Medical Products, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K962220 (Marquest Medical Products, Inc., 1997) 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 | — |
https://510kreport.com/device/K903138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K903138: Marquest SCT 3000, Heated Humidification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K903138
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026