Cleared Traditional

K925022 - SURGICAL TRAY (STERILE)

K925022 is an FDA 510(k) clearance for SURGICAL TRAY (STERILE), manufactured by Customed, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRD cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K925022 · Customed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K925022

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 89d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

LRD Device Classification - Class 1, General Controls

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.