Cleared Traditional

K914845 - M170 PNEUMATICALLY OPERATED OSCILLATING SAW

K914845 is an FDA 510(k) clearance for M170 PNEUMATICALLY OPERATED OSCILLATING SAW, manufactured by Desutter Medical , Ltd.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K914845 · Desutter Medical , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
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Jan 1992
Decision
77d
Days
Class 1
Risk

K914845 is an FDA 510(k) clearance for the M170 PNEUMATICALLY OPERATED OSCILLATING SAW. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Desutter Medical , Ltd. (Kings Langley Herts, GB). The FDA issued a Cleared decision on January 13, 1992 after a review of 77 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.

FDA 510(k) Submission Details - K914845

510(k) Number K914845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1991
Decision Date January 13, 1992
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
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 43
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K914845.
THE DE SOUTTER M182 DRILL
K930785 · De Soutter Medical, Ltd. · Oct 1993
MEDNEXT 1000 BONE DISSECTING SYSTEM
K926547 · Mednext, Inc. · Jul 1993
HHI PNEUMATIC ROTARY DRILL
K922661 · H&H Instruments · Sep 1992
JOHNSON AND JOHNSON POWER SYSTEM
K913629 · Johnson & Johnson Orthopaedics, Inc. · Nov 1991
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949 · Micro-Aire Surgical Instruments, Inc. · Nov 1990
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
K903713 · Micro-Aire Surgical Instruments, Inc. · Sep 1990