Nebulizer/Humidifier

FDA 510(k) K781537 · Chemetron Medical Products, Inc.

Substantially Equivalent

510(k) numberK781537

Submission

Device name
Nebulizer/Humidifier
Applicant
Chemetron Medical Products, Inc.
Mchenry, IL, US
Received
September 1, 1978
Decision date
October 10, 1978
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

Other 510(k)s with product code BTT

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K262268Optiflow Oxygen Kit (AA484J)BTT · Special Fisher and Paykel Healthcare Limited08/27/2026SE
K254078HVT 2.0BTT · Traditional Vapotherm, Inc.04/13/2026SE
K251448FL-10000U Respiratory HumidifierBTT · Traditional Flexicare Medical Limited.01/16/2026SE
K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional Laboratorios Biogalenic S.A. DE C.V.01/14/2026SE
K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special Fisher & Paykel Healthcare, Ltd.12/19/2025SE
K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional Medline Industries, LP07/02/2025SE
K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special Fisher & Paykel Healthcare, Ltd.06/25/2025SE
K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional Laboratorios Biogalenic S.A. DE C.V.01/30/2025SE
K241778Hudson RCI Comfort Flo® CubCannula™BTT · Traditional Medline Industries, LP12/19/2024SE
K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional Medline Industries, LP09/27/2024SE

More from Medline Industries, LP

510(k)DeviceDecision
K781706Respirator/Gill 1/SIMVCBO · Traditional 01/22/1979SE
K781542Heated NebulizerCAF · Traditional 10/10/1978SE
K781541FlometerCAX · Traditional 09/26/1978SE

Questions and answers

When was Nebulizer/Humidifier cleared by the FDA?

Nebulizer/Humidifier (K781537) received a 510(k) decision of Substantially Equivalent on October 10, 1978, 39 days after the submission was received.

What is the product code of K781537?

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