Smooth-Flo Circuit

FDA 510(k) K010402 · Hudson Respiratory Care, Inc.

Substantially Equivalent

510(k) numberK010402

Submission

Device name
Smooth-Flo Circuit
Applicant
Hudson Respiratory Care, Inc.
Temecula, CA, US
Received
February 12, 2001
Decision date
March 14, 2001
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5450
Specialty
Anesthesiology

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Questions and answers

When was Smooth-Flo Circuit cleared by the FDA?

Smooth-Flo Circuit (K010402) received a 510(k) decision of Substantially Equivalent on March 14, 2001, 30 days after the submission was received.

What is the product code of K010402?

The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.