510(k) · Cleared
ClearedTaga Velocity Passover Humidifier with Heater, Model TM1000H
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 Mar 4, 2004 as substantially equivalent to K031179 (Taga Medical Technologies, Inc., 2003) and 1 other predicate after a 6-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Mar 4, 2004
- Review
- 6 days
- Class
- Class II
- Product code
- BTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010578 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK010578 Taga Velocity Passover Humidifier Unit, Model MP1017Taga Medical Technologies, Inc. · 2001
- 1 generation backK031179 Taga Velocity HumidifierTaga Medical Technologies, Inc. · 2003
- This deviceK040507 Taga Velocity Passover Humidifier with Heater, Model TM1000HTaga Medical Technologies, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010578 | Taga Velocity Passover Humidifier Unit, Model MP1017 | Taga Medical Technologies, Inc. | 2001 | — |
| −1 | K031179 | Taga Velocity Humidifier | Taga Medical Technologies, Inc. | 2003 | — |
| 0 (this device) | 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 |
| 2002 | 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 |
|---|---|---|---|
| * | K031179 | Taga Velocity HumidifierSummary page 1…ion Respiratory gas humidifier, 21 CFR 868.5450 Predicate: TAGA Medical Technologies, Inc., Velocity Passover Humidifier, K031179 market clearance date July 17, 2003, which is used as a component for the new Velocity Humidifier Heat… | 2003 |
| * | K020900 | Devilbiss Model 9200D Heated Humidifier SystemSummary page 1…y Humidifier Heater TM1000H device and the Sumrise Medical HHG, Inc. Devilbiss Model 9200D heated Humidfier System, K020900, market clearance date June 03, 2002. Description The following is a summary of the Velocity Passover Humidifier… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a 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.
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 with Velocity Humidifier Heater TM1000H is a respiratory positive airway pressure accessory intended to add moisture to the air stream gases for administration to the patient. 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 H2A, and do not have automatic pressure titration capabilities.
For single patient use in home, physician's office or hospital / institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040507: Taga Velocity Passover Humidifier with Heater, Model TM1000H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040507
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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