510(k) · Cleared
Recalled · Class II · 2012Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier (Remanufacturer), Model# 425-00,425-00R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Apr 23, 2007 as substantially equivalent to K923946 (Hudson Respiratory Care, Inc., 1994) and 1 other predicate after a 125-day review. Its family tree reaches back 5 generations to 1992. 2 of the 13 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 23, 2007
- Review
- 125 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913368 (1992). 10 ancestors in all, the oldest K902506 (1991). 2 later devices descend from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 4 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 3 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 2 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 1 generation backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- This deviceK063758 Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated…Teleflex Medical · 2007
- 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 |
|---|---|---|---|---|---|
| −5 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −4 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −3 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −2 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −1 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| 0 (this device) | K063758 | Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier… | Teleflex Medical | 2007 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 2000 | 1 | 0 |
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 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? (2)
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 |
|---|---|---|---|
| * | K923946 | Conchatherm IV Heated Molecular HumidifierSummary page 2…re. G. Substantial Equivalence The device is similar in intended use, materials, design, and performance characteristics to the Teleflex Medical ConchaTherm IV® (K923946) and the Fisher & Paykel MR850 (K033710). The determination of substantial equivalence for this device was based on a detai… | 1994 |
| * | K033710 | MR850 Respiratory Humidifier, Model MR850JHUSummary page 2…ice is similar in intended use, materials, design, and performance characteristics to the Teleflex Medical ConchaTherm IV® (K923946) and the Fisher & Paykel MR850 (K033710). The determination of substantial equivalence for this device was based on a detailed device description, performance testing… | 2004 |
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 12, 2012 | Class II | Z-2036-2012 | Device Design | Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment. |
| Jan 12, 2010 | Not classified | Z-1040-2010 | Device Design | When turned on, the Neptune heater may cause an artifact on the patient's heart monitor. |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K131912 (Teleflex, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K923946.
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. 2007, 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?
The ConchaTherm® Neptune TM 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 TM 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/K063758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063758: Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier (Remanufacturer), Model# 425-00,425-00R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063758
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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