Cleared Traditional

K833874 - SHEA MIDDLE EAR MICRODRILL

K833874 is an FDA 510(k) clearance for SHEA MIDDLE EAR MICRODRILL, manufactured by Applied Research Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 227-day FDA review.

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

FDA 510(k) Submission Details - K833874

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.

ERL Device Classification - Class 2, Special Controls

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 59
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K833874.
TREACE DRILL SYSTEM
K862807 · Treace Medical, Inc. · Aug 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331 · Micro-Aire Surgical Instruments, Inc. · Jan 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332 · Micro-Aire Surgical Instruments, Inc. · Jan 1986
TORX OR TYPE MICRO MOTOR HANDPIECE
K822008 · Kelleher Corp. · Aug 1982
FISCH DRILL SYSTEM
K792159 · Jedmed Instrument Co. · Nov 1979
WOMED NICRO-CRAFT POWER SYSTEM
K791407 · Xomed, Inc. · Aug 1979