Cleared Traditional

K844162 - EZ 505

K844162 is an FDA 510(k) clearance for EZ 505, manufactured by Aeg Power Tool Corp.. The device is a Class 1 Orthopedic device with product code KIJ cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K844162 · Aeg Power Tool Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
138d
Days
Class 1
Risk

K844162 is an FDA 510(k) clearance for the EZ 505. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Aeg Power Tool Corp. (Norwich, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K844162

510(k) Number K844162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1984
Decision Date March 11, 1985
Days to Decision 138 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 122d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

KIJ Device Classification - Class 1, General Controls

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

All 21
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K844162.
STERNAL POWER AWL
K873766 · Bowen & Company, Inc. · Nov 1988
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III
K864137 · Bio-Rad · Nov 1986
FLUTED SUCTION MENISCAL CUTTER
K850789 · T. Korossurgical Instruments Corp. · Jun 1985
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K822790 · Xomed, Inc. · Oct 1982
INTRA-ARTICULAR SURGICAL SYSTEM
K820367 · Dyonics, Inc. · May 1982
DRILL, CORDLESS SURGICAL
K790063 · Richard'S Medical Equip., Inc. · Feb 1979
K844162 · EZ 505
Download PDF Aeg Power Tool Corp.