# K040507: Taga Velocity Passover Humidifier with Heater, Model TM1000H

- Pathway: 510(k) (Traditional)
- Applicant: Taga Medical Technologies, Inc.
- Decided: Mar 4, 2004 after 6 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010578 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031179: Taga Velocity Humidifier, Taga Medical Technologies, Inc. (2003) Summary page 1.
- K020900: Devilbiss Model 9200D Heated Humidifier System, Sunrise Medical Hhg, Inc. (2002) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K040507
Methodology: https://510kreport.com/methodology