Cleared Traditional

AMSCO STERILE RECOVERIES SURGICAL PACKS (K932522) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K932522 · Amsco Sterile Recoveries, Inc. · Ear, Nose, Throat device
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Sep 1994
Decision
472d
Days
Class 1
Risk

K932522 is an FDA 510(k) clearance for the AMSCO STERILE RECOVERIES SURGICAL PACKS. Classified as Applicator, Ent Drug (product code LRD), Class I - General Controls.

Submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 472 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Amsco Sterile Recoveries, Inc. devices

Submission Details

510(k) Number K932522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1993
Decision Date September 09, 1994
Days to Decision 472 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
383d slower than avg
Panel avg: 89d · This submission: 472d
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.