Cleared Traditional

K203400 - Corrugated tube with mouthpiece accessory

K203400 is an FDA 510(k) clearance for Corrugated tube with mouthpiece accessory, manufactured by Trudell Medical International. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K203400 · Trudell Medical International · Anesthesiology device
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Jun 2021
Decision
207d
Days
Class 2
Risk

K203400 is an FDA 510(k) clearance for the Corrugated tube with mouthpiece accessory. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Trudell Medical International (London, CA). The FDA issued a Cleared decision on June 14, 2021 after a review of 207 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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.

View all Trudell Medical International devices

FDA 510(k) Submission Details - K203400

510(k) Number K203400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2020
Decision Date June 14, 2021
Days to Decision 207 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 140d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 196
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K203400.
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K201167 · Airehealth, Inc. · Dec 2020
Portable Mesh Nebulizer
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K200063 · Trudell Medical International · Jul 2020