Cleared Traditional

SHEA MIDDLE EAR MICRODRILL (K833874) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833874 · Applied Research Corp. · Ear, Nose, Throat device
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Jun 1984
Decision
227d
Days
Class 2
Risk

K833874 is an FDA 510(k) clearance for the SHEA MIDDLE EAR MICRODRILL. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Applied Research Corp. (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 227 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - 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 Applied Research Corp. devices

Submission Details

510(k) Number K833874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1983
Decision Date June 22, 1984
Days to Decision 227 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 89d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 14
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K833874.
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262 · KARL STORZ Endoscopy-America, Inc. · Dec 2005
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · KARL STORZ Endoscopy-America, Inc. · Apr 2001
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · KARL STORZ Endoscopy-America, Inc. · Mar 1995