510(k) · Cleared
ClearedSmooth-Flo Circuit
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 Mar 14, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 4 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Mar 14, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly. 2 of the 4 devices in this family, counting this one, have a Class I recall.
- This deviceK010402 Smooth-Flo CircuitHudson Respiratory Care, Inc. · 2001
- 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)
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010402 | Smooth-Flo Circuit | Hudson Respiratory Care, Inc. | 2001 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 1 | 1 |
| 2017 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061736 | Comfort Flo Humidification System and Nasal Cannula | 2006 | 2 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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?
- 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 | — |
https://510kreport.com/device/K010402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010402: Smooth-Flo Circuit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010402
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026