Cleared Traditional

K930507 - CUSTOM ORTHOPAEDIC TRAYS (PACKS)

K930507 is an FDA 510(k) clearance for CUSTOM ORTHOPAEDIC TRAYS (PACKS), manufactured by Associated Medical Products Co.. The device is a Class 1 Orthopedic device with product code HTS cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K930507 · Associated Medical Products Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K930507

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 122d · This submission: 386d
Pathway characteristics
Predicate-based equivalence.

HTS Device Classification - Class 1, General Controls

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.

Regulatory Peers - HTS Knife, Orthopedic

Devices cleared under the same product code (HTS) and FDA review panel - the closest regulatory comparables to K930507.
ACUFLEX DISPOSABLE KNIVES
K933921 · Acufex Microsurgical, Inc. · Jan 1994
RETROGRADE KNIFE, DISPOSABLE #TM-1613
K873711 · Arthropedics, Inc. · Nov 1987
TRIANGULAR KNIFE, DISPOSABLE #TM-1611
K873713 · Arthropedics, Inc. · Nov 1987
BANANA KNIFE, DISPOSABLE #TM-1612
K873714 · Arthropedics, Inc. · Nov 1987
STANDARD KNIFE, DISPOSABLE #TM-1610
K873712 · Arthropedics, Inc. · Oct 1987
ARTHROSCOPE OPERATIVE KNIFE SET
K771851 · Richard Wolf Medical Instruments Corp. · Oct 1977