Cleared Traditional

K925022 - SURGICAL TRAY (STERILE) (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K925022 · Customed, Inc. · Ear, Nose, Throat device
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Apr 1993
Decision
214d
Days
Class 1
Risk

K925022 is an FDA 510(k) clearance for the SURGICAL TRAY (STERILE). Classified as Applicator, Ent Drug (product code LRD), Class I - General Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on April 26, 1993 after a review of 214 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Customed, Inc. devices

Submission Details

510(k) Number K925022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1992
Decision Date April 26, 1993
Days to Decision 214 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 89d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRD Applicator, Ent Drug
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.