510(k) · Cleared
ClearedHudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Oct 26, 2023 as substantially equivalent to K161719 (Salter Labs, 2017) after a 240-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Oct 26, 2023
- Review
- 240 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K991484 (1999). No later device cites it as a predicate yet.
- Root · 4 generations backK991484 Airlife Bubble Humidifer, Model 002003 and 002006Allegiance Healthcare Corp. · 1999
- 3 generations backK041963 American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and…American Bantex Corp. · 2004
- 2 generations backK113542 Salter Labs Bubble Humidifier (High Flow)Salter Labs, Arvin Facility · 2012
- 1 generation backK161719 Salter Labs Bubble HumidifierSalter Labs · 2017
- This deviceK230559 Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve…Medline Industries, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991484 | Airlife Bubble Humidifer, Model 002003 and 002006 | Allegiance Healthcare Corp. | 1999 | — |
| −3 | K041963 | American Bantex Humidifier, Dry, Bubble, Models B9000, 3 Psi and B9100, 6 Psi | American Bantex Corp. | 2004 | — |
| −2 | K113542 | Salter Labs Bubble Humidifier (High Flow) | Salter Labs, Arvin Facility | 2012 | — |
| −1 | K161719 | Salter Labs Bubble Humidifier | Salter Labs | 2017 | — |
| 0 (this device) | K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230)… | Medline Industries, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K161719 | Salter Labs Bubble HumidifierSummary page 5…510(k) Number Predicate Device Name / Manufacturer Primary Predicate K161719 Salter Labs Bubble Humidifier The predicate devices have not been subject to a desi… | 2017 |
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 24 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- None of the 4 ancestors has a recall.
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. 2023, this device’s year, is highlighted.
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?
Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230559: Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230559
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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