Cleared Traditional

K930507 - CUSTOM ORTHOPAEDIC TRAYS (PACKS) (FDA 510(k) Clearance)

Class I Orthopedic device.

K930507 · Associated Medical Products Co. · Orthopedic device
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Feb 1994
Decision
386d
Days
Class 1
Risk

K930507 is an FDA 510(k) clearance for the CUSTOM ORTHOPAEDIC TRAYS (PACKS). Classified as Knife, Orthopedic (product code HTS), Class I - General Controls.

Submitted by Associated Medical Products Co. (St. Louis Park, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Associated Medical Products Co. devices

Submission Details

510(k) Number K930507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date February 22, 1994
Days to Decision 386 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 122d · This submission: 386d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTS Knife, Orthopedic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.