510(k) · Cleared
ClearedTaga Velocity Humidifier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taga Medical Technologies, Inc. · BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Cleared on Jul 17, 2003 as substantially equivalent to K010578 (Taga Medical Technologies, Inc., 2001) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jul 17, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010578 (2001). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK010578 Taga Velocity Passover Humidifier Unit, Model MP1017Taga Medical Technologies, Inc. · 2001
- This deviceK031179 Taga Velocity HumidifierTaga Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK040507 Taga Velocity Passover Humidifier with Heater, Model TM1000HTaga Medical Technologies, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K040507Taga Velocity Passover Humidifier with Heater, Model TM1000HTaga Medical Technologies, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010578 | Taga Velocity Passover Humidifier Unit, Model MP1017 | Taga Medical Technologies, Inc. | 2001 | — |
| 0 (this device) | K031179 | Taga Velocity Humidifier | Taga Medical Technologies, Inc. | 2003 | — |
| +1 | K040507 | Taga Velocity Passover Humidifier with Heater, Model TM1000H | Taga Medical Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
Planning a device in BTT? 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 |
|---|---|---|---|
| * | K010578 | Taga Velocity Passover Humidifier Unit, Model MP1017Summary page 1…Name rAGA VelocityTMPassover Humidifier Classification iespiratory gas humidifier, 21 CFR 868.5450.73BTT Predicate: rAGA VelocitvTMHumidifier. (K#010578) 3evilbiss 91odD (K#003626) Description rhe TAGA Velocity Passover Humidifier is a plastic housing co… | 2001 |
| * | K003626 | Devilbiss HumidifierSummary page 1…er Classification iespiratory gas humidifier, 21 CFR 868.5450.73BTT Predicate: rAGA VelocitvTMHumidifier. (K#010578) 3evilbiss 91odD (K#003626) Description rhe TAGA Velocity Passover Humidifier is a plastic housing comprised of two (2) halves permanently joined to… | 2001 |
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 |
|---|---|---|---|
| K040507 | Taga Velocity Passover Humidifier with Heater, Model TM1000H | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K040507 (Taga Medical Technologies, Inc., 2004) 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.
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 TAGA Velocity Passover humidifier is a respiratory positive airway
pressure accessory intended to add moisture to the airstream gases for
administration to the patient. The humidifier increases the vapor content of the
air as it passes through the device (Passover) and is directed by the array of
baffles over the surface of a body of water. The humidifier can be used with
standard CPAP and or Bi-level Positive Airway Pressure (BIPAP) devices which
have a maximum operating pressure of 20 cm H20, and do not have automatic
pressure titration capabilities.
Environment of Use / Patient Population:
For single patient use in home, physician’s office or hospitaVinstitutiona1
environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031179: Taga Velocity Humidifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031179
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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