TNI softFlow 50

Q: When was TNI softFlow 50 cleared by the FDA?

TNI softFlow 50 (K180474) received a 510(k) decision of Substantially Equivalent on October 18, 2018, 238 days after the submission was received.

Q: What is the product code of K180474?

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) K180474 · Tni Medical AG

Substantially Equivalent

510(k) numberK180474

Submission

Device name: TNI softFlow 50
Applicant: Tni Medical AG
Wuerzburg, DE
Received: February 22, 2018
Decision date: October 18, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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

510(k)	Device	Applicant	Decision
K262268	Optiflow Oxygen Kit (AA484J)BTT · Special	Fisher and Paykel Healthcare Limited	08/27/2026SE
K254078	HVT 2.0BTT · Traditional	Vapotherm, Inc.	04/13/2026SE
K251448	FL-10000U Respiratory HumidifierBTT · Traditional	Flexicare Medical Limited.	01/16/2026SE
K251419	Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional	Laboratorios Biogalenic S.A. DE C.V.	01/14/2026SE
K253479	Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special	Fisher & Paykel Healthcare, Ltd.	12/19/2025SE
K250312	Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional	Medline Industries, LP	07/02/2025SE
K251611	Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special	Fisher & Paykel Healthcare, Ltd.	06/25/2025SE
K242717	Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional	Laboratorios Biogalenic S.A. DE C.V.	01/30/2025SE
K241778	Hudson RCI Comfort Flo® CubCannulaBTT · Traditional	Medline Industries, LP	12/19/2024SE
K240163	Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional	Medline Industries, LP	09/27/2024SE

Questions and answers

When was TNI softFlow 50 cleared by the FDA?

TNI softFlow 50 (K180474) received a 510(k) decision of Substantially Equivalent on October 18, 2018, 238 days after the submission was received.

What is the product code of K180474?

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