Cleared Traditional

K862852 - MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HAL...

K862852 is an FDA 510(k) clearance for MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HAL..., manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFF cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K862852 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery device
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Aug 1986
Decision
13d
Days
Class 1
Risk

K862852 is an FDA 510(k) clearance for the MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR. Classified as Bur, Surgical, General & Plastic Surgery (product code GFF), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on August 11, 1986 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro-Aire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K862852

510(k) Number K862852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date August 11, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

GFF Device Classification - Class 1, General Controls

Product Code GFF Bur, Surgical, General & Plastic Surgery
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 - GFF Bur, Surgical, General & Plastic Surgery

Devices cleared under the same product code (GFF) and FDA review panel - the closest regulatory comparables to K862852.
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