Cleared Traditional

K903650 - OSCILLATING SAW BLADES # SO-305

K903650 is an FDA 510(k) clearance for OSCILLATING SAW BLADES # SO-305, manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K903650 · Micro-Aire Surgical Instruments, Inc. · Orthopedic device
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Sep 1990
Decision
32d
Days
Class 1
Risk

K903650 is an FDA 510(k) clearance for the OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on September 14, 1990 after a review of 32 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 - K903650

510(k) Number K903650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date September 14, 1990
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-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 - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 40
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K903650.
ACUFEX STERILE DRILLS
K931837 · Acufex Microsurgical, Inc. · Jan 1994
CKS OSCILLATING SAW BLADE
K921131 · Techmedica, Inc. · Jun 1992
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
K902525 · Buckman Co., Inc. · Nov 1990
HALL MODULAR ACETABULAR REAMER SYSTEM
K902332 · Zimmer, Inc. · Jun 1990
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198 · Zimmer, Inc. · Sep 1989
ACE SCREW REMOVAL TREPHINE
K882008 · Buckman Co., Inc. · Jun 1988