510(k) · Cleared
Recalled · Class II · 2026MODEL 780
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 Jul 7, 2003 as substantially equivalent to K881625 (Respiratory Care, Inc., 1988) after a 67-day review. Its family tree reaches back 1 generation to 1988. 2 of the 6 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 7, 2003
- Review
- 67 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881625 (1988). 4 later devices descend from it, 2 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK881625 Conchatherm Iii Plus Dual Heat Wire Servo ControllRespiratory Care, Inc. · 1988
- This deviceK031383 MODEL 780Hudson Respiratory Care, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK061736 Comfort Flo Humidification System and Nasal CannulaTeleflex Medical · 2006
- Descendant · 2 generations on · 1 of its ownK131912 Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification…Teleflex, Inc. · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK162242 Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK140556 Conchasmart Breathing CircuitTeleflex, Inc. · 2014
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K061736Comfort Flo Humidification System and Nasal CannulaTeleflex Medical · 2006 · cites it directly2descendants
- K131912Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…Teleflex, Inc. · 2014 · 2 generations on1descendant
- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · 3 generations on0descendants
- K140556Conchasmart Breathing CircuitTeleflex, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881625 | Conchatherm Iii Plus Dual Heat Wire Servo Controll | Respiratory Care, Inc. | 1988 | — |
| 0 (this device) | K031383 | MODEL 780 | Hudson Respiratory Care, Inc. | 2003 | — |
| +1 | K061736 | Comfort Flo Humidification System and Nasal Cannula | Teleflex Medical | 2006 | — |
| +2 | K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System… | Teleflex, Inc. | 2014 | Class I |
| +3 | K162242 | Comfort Flo Humidification System | Teleflexmedical, Inc. | 2017 | Class I |
| +1 | K140556 | Conchasmart Breathing Circuit | Teleflex, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 2 | 1 |
| 2017 | 1 | 1 |
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.
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? (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 |
|---|---|---|---|
| * | K881625 | Conchatherm Iii Plus Dual Heat Wire Servo ControllSummary page 1…7.1 (Circuit) Breathing Circuit 8.0 Predicate Devices 8.1 (Circuit) Current Hudson RCI Adult Heated Wire Circuit cleared in 510(k) submission K881625 9.0 Device Description Breathing circuit that is intended to administer medical gases to a patient. It provides both an inh… | 1988 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2026 | Class II | Z-2991-2026 | Under Investigation by firm | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage.… |
| Jul 9, 2014 | Class II | Z-2107-2014 | Nonconforming Material/Component | The temperature probe does not properly connect to the temperature port. |
| Apr 17, 2014 | Class II | Z-0419-2016 | Process control | Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed. |
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 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K061736 (Teleflex Medical, 2006) has gone furthest, with 2 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 Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031383: MODEL 780.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031383
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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