Modified Conchatherm III Controlled Heater

Q: What is the product code of K884150?

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

FDA 510(k) K884150 · Respiratory Care, Inc.

Substantially Equivalent

510(k) numberK884150

Submission

Device name: Modified Conchatherm III Controlled Heater
Applicant: Respiratory Care, Inc.
Arlington Heights, IL, US
Received: October 3, 1988
Decision date: November 21, 1988
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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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K251611	Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special	Fisher & Paykel Healthcare, Ltd.	06/25/2025SE
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K241778	Hudson RCI Comfort Flo® CubCannulaBTT · Traditional	Medline Industries, LP	12/19/2024SE
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More from Medline Industries, LP

510(k)	Device	Decision
K892230	Rci Viral/Bacterial FilterCAH · Traditional	08/28/1989SE
K881625	Conchatherm III Plus Dual Heat Wire Servo ControllBZE · Traditional	06/21/1988SE
K864147	AquavalveBYH · Traditional	12/05/1986SE
K863955	Colby Level AlarmBTT · Traditional	11/07/1986SE
K861555	Circapak Universal Volume Ventilator CircuitBZD · Traditional	06/05/1986SE
K834151	Conchatherm LHF Humidifier HeaterBTT · Traditional	01/13/1984SE
K833974	Aquapak 020 Humidifier AdapterBTT · Traditional	12/16/1983SE
K832453	Slimb Single Limb Breathing CircuitCAI · Traditional	10/27/1983SE
K811524	AquacadeLHC · Traditional	07/01/1981SE
K811073	A QuapakBTT · Traditional	04/29/1981SE

Questions and answers

When was Modified Conchatherm III Controlled Heater cleared by the FDA?

Modified Conchatherm III Controlled Heater (K884150) received a 510(k) decision of Substantially Equivalent on November 21, 1988, 49 days after the submission was received.

What is the product code of K884150?

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