510(k) · Cleared
Recalled · 2011Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO. 780-40, 780-41, 780-42, 780-43
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hudson Respiratory Care, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on May 24, 2000 after a 231-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 3 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once.
- Decided
- May 24, 2000
- Review
- 231 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- This deviceK993355 Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit…Hudson Respiratory Care, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK131912 Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification…Teleflex, Inc. · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK162242 Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · Recalled (Class I)
Class I recalls in this family
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 |
|---|---|---|---|---|---|
| 0 (this device) | K993355 | Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO.… | Hudson Respiratory Care, Inc. | 2000 | — |
| +1 | K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System… | Teleflex, Inc. | 2014 | Class I |
| +2 | K162242 | Comfort Flo Humidification System | Teleflexmedical, Inc. | 2017 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2017 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart… Class I | 2014 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 6, 2011 | Not classified | Z-2790-2011 | Packaging | The packaging may not have been properly sealed, and therefore the sterility of the product cannot be guaranteed. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart ColumnTeleflex, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K131912 (Teleflex, Inc., 2014) 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?
When used with Hudson RCI CONCHATHERM healers and Hudson RCI ventilator circuits, the 385-40 Concha Column provides heated humidification for paticnts with and without an artificial airway in place,
When used with the Hudson RCI CONCHATHERM heater and Cat. No. 385-40 column the 780-40, 780-41, 780-42, 780-43 circuit provides a gas conduit from the ventilator to the patient and back to the ventilator, and includes both conventional and heated wire circuit modes of neonatal ventilation.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993355: Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO. 780-40, 780-41, 780-42, 780-43.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993355
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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