510(k) · Cleared
Recalled · Class I · 2019Comfort Flo Humidification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Jan 19, 2017 as substantially equivalent to K131912 (Teleflex, Inc., 2014) after a 162-day review. Its family tree reaches back 7 generations to 1992. 2 of the 18 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jan 19, 2017
- Review
- 162 days
- Class
- Class II
- Product code
- BTT
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913368 (1992). 17 ancestors in all, the oldest K881625 (1988). No later device cites it as a predicate yet. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 6 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 5 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 4 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 3 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 2 generations backK061736 Comfort Flo Humidification System and Nasal CannulaTeleflex Medical · 2006
- 1 generation backK131912 Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification…Teleflex, Inc. · 2014 · Recalled (Class I)
- This deviceK162242 Comfort Flo Humidification SystemTeleflexmedical, Inc. · 2017
Class I recalls in this family
- K131912 Conchatherm Neptune Heated Humidifier, Comfort…direct predicate · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −6 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −5 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −4 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −3 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −2 | K061736 | Comfort Flo Humidification System and Nasal Cannula | Teleflex Medical | 2006 | — |
| −1 | K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System… | Teleflex, Inc. | 2014 | Class I |
| 0 (this device) | K162242 | Comfort Flo Humidification System | Teleflexmedical, Inc. | 2017 | — |
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 |
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 |
|---|---|---|---|
| * | K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…Summary page 4…sthesiology E. Predicate Device This submission demonstrates substantial equivalence to the following predicate devices: • Comfort Flo Humidification System – K131912 F. Device Description The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gase… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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-1113-2020 | 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-1112-2020 | 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. |
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 17 ancestors have a recall of any class; 1 has a Class I 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. 2017, 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 Comfort Flo Humidification System provides a continuous flow of heated and humidified gas to spontaneously breathing patients. It is indicated for single use by neonate/infant, pediatric, and adult patients in professional healthcare environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162242 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162242: Comfort Flo Humidification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162242
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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