Cleared Traditional

K851443 - MICRO-AIRE OSCILLATING SAW

K851443 is an FDA 510(k) clearance for MICRO-AIRE OSCILLATING SAW, manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K851443 · Micro-Aire Surgical Instruments, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
22d
Days
Class 1
Risk

K851443 is an FDA 510(k) clearance for the MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on May 3, 1985 after a review of 22 days - a notably fast clearance cycle.

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: 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 - K851443

510(k) Number K851443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date May 03, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & 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 - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K851443.
ORTHOPEDIC DRILL GUIDE
K871287 · Orthopedic Systems, Inc. · Apr 1987
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314 · The Anspach Effort, Inc. · Nov 1986
REPLACEMENT HOSES
K861405 · Micro-Aire Surgical Instruments, Inc. · Apr 1986
ACUFEX ARTHROSCOPIC SHAVER
K844130 · Acufex Microsurgical, Inc. · Mar 1985
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831 · Cabot Medical Corp. · Apr 1984
ANSPACH 65,000
K831756 · The Anspach Effort, Inc. · Sep 1983