Cleared Traditional

K813093 - RICHARDS ACETABULAR BRUSH

K813093 is an FDA 510(k) clearance for RICHARDS ACETABULAR BRUSH, manufactured by Richard'S Medical Equip., Inc.. The device is a Class 1 General & Plastic Surgery device with product code HTR cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K813093 · Richard'S Medical Equip., Inc. · General & Plastic Surgery device
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Nov 1981
Decision
18d
Days
Class 1
Risk

K813093 is an FDA 510(k) clearance for the RICHARDS ACETABULAR BRUSH. Classified as Rasp (product code HTR), Class I - General Controls.

Submitted by Richard'S Medical Equip., Inc. (Walker, US). The FDA issued a Cleared decision on November 20, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Richard'S Medical Equip., Inc. devices

FDA 510(k) Submission Details - K813093

510(k) Number K813093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date November 20, 1981
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

HTR Device Classification - Class 1, General Controls

Product Code HTR Rasp
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - HTR Rasp

Devices cleared under the same product code (HTR) and FDA review panel - the closest regulatory comparables to K813093.
ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
K870329 · Biodynamic Technologies, Inc. · Feb 1987
BIODYNAMICS SMALL JOINT BRUSH #1203
K870333 · Biodynamic Technologies, Inc. · Feb 1987
BIODYNAMICS FEMORAL CANAL BRUSH #1201
K870349 · Biodynamic Technologies, Inc. · Feb 1987
INTERMEDULLARY BRUSH
K771016 · Howmedica Corp. · Jan 1978
RASPS FOR SCRAPING BONE
K771745 · Depuy, Inc. · Sep 1977
PROSTHESIS, TOTAL HIP-RASP
K760109 · Orthopedic Equipment Co., Inc. · Jul 1976