Minitrop Aerosal, Prodomo Aerosal and

FDA 510(k) K830913 · Medlog GmbH Marketing Services

Substantially Equivalent

510(k) numberK830913

Submission

Device name
Minitrop Aerosal, Prodomo Aerosal and
Applicant
Medlog GmbH Marketing Services
Mchenry, IL, US
Received
March 21, 1983
Decision date
May 25, 1983
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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K262268Optiflow Oxygen Kit (AA484J)BTT · Special Fisher and Paykel Healthcare Limited08/27/2026SE
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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
K832086Use 77 Ultrasonic NebulizerCAF · Traditional 07/19/1983SE
K831325NutromatGBB · Traditional 06/02/1983SE
K813455Pump & DetectorFRN · Traditional 01/05/1982SE
K810155Dop 84 · Traditional 05/01/1981SE

Questions and answers

When was Minitrop Aerosal, Prodomo Aerosal and cleared by the FDA?

Minitrop Aerosal, Prodomo Aerosal and (K830913) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 65 days after the submission was received.

What is the product code of K830913?

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