510(k) · Cleared
Recalled · Class I · 2019Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Mar 6, 2014 as substantially equivalent to K063758 (Teleflex Medical, 2007) and 2 other predicates after a 253-day review. Its family tree reaches back 6 generations to 1992. 2 of the 18 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Mar 6, 2014
- Review
- 253 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 3 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913368 (1992). 16 ancestors in all, the oldest K881625 (1988). 1 later device descends from it, 1 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 5 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 4 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 3 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 2 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK061736 Comfort Flo Humidification System and Nasal CannulaTeleflex Medical · 2006
- This deviceK131912 Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification…Teleflex, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK162242 Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · Recalled (Class I)
Class I recalls in this family
- K162242 Comfort Flo Humidification Systemcites it directly · 2017
Most influential descendants
Showing 1 of 1 · See all- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −5 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −4 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −3 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −2 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K061736 | Comfort Flo Humidification System and Nasal Cannula | Teleflex Medical | 2006 | — |
| 0 (this device) | K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System… | Teleflex, Inc. | 2014 | — |
| +1 | K162242 | Comfort Flo Humidification System | Teleflexmedical, Inc. | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K063758 | Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier…Summary page 2…E. Predicate Device This submission demonstrates substantial equivalence to the following predicate devices: * ConchaTherm Neptune Heated Humidifier - K063758 * Minimal Compliance Column - K993355 * Comfort Flo Humidification System - K061 736 F. Device Description Th… | 2007 |
| * | K993355 | Hudson Rci Concha Column, Cat. NO. 385-40 and Hudson Rci Circuit, Cat. NO. 780-40…Summary page 2…onstrates substantial equivalence to the following predicate devices: * ConchaTherm Neptune Heated Humidifier - K063758 * Minimal Compliance Column - K993355 * Comfort Flo Humidification System - K061 736 F. Device Description The ConchaTherm Neptune Heated Humidifier is an… | 2000 |
| * | K061736 | Comfort Flo Humidification System and Nasal CannulaSummary page 2…dicate devices: * ConchaTherm Neptune Heated Humidifier - K063758 * Minimal Compliance Column - K993355 * Comfort Flo Humidification System - K061 736 F. Device Description The ConchaTherm Neptune Heated Humidifier is an active heated humidifier designed to provide heat an… | 2006 |
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 |
|---|---|---|---|
| K162242 | Comfort Flo Humidification System Class I | 2017 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2019 | Class I | Z-1115-2020 | Device Design | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy. |
| Dec 13, 2019 | Class I | Z-1114-2020 | Device Design | There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy. |
| Apr 1, 2015 | Class II | Z-1558-2015 | Nonconforming Material/Component | Customer complaints were received of power to the unit ceasing and the display going blank. |
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.
- K162242Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K162242 (Teleflexmedical, Inc., 2017) 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. 2014, 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?
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients. When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place. The ConchaTherm® Neptune® is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal…
Read the full statement (128 words)
To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.
When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
The ConchaTherm® Neptune® is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits.
The ConchaTherm® Neptune® can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or non-flammable anesthesia gases to help maintain patient body temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131912: Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131912
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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