Cleared Traditional

K180474 - TNI softFlow 50 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180474 · Tni Medical AG · Anesthesiology device
Oct 2018
Decision
238d
Days
Class 2
Risk

K180474 is an FDA 510(k) clearance for the TNI softFlow 50. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Tni Medical AG (Wuerzburg, DE). The FDA issued a Cleared decision on October 18, 2018 after a review of 238 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K180474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2018
Decision Date October 18, 2018
Days to Decision 238 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 225d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 16
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K180474.
FL-10000U Respiratory Humidifier
K251448 · Flexicare Medical Limited. · Jan 2026
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K251419 · Laboratorios Biogalenic S.A. DE C.V. · Jan 2026
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
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Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant
K250312 · Medline Industries, LP · Jul 2025
Optiflow+ Nasal Cannula - Small (OPT942)
K251611 · Fisher &Paykel Healthcare , Ltd. · Jun 2025
Hudson RCI Comfort Flo® CubCannula™
K241778 · Medline Industries, LP · Dec 2024