Cleared Traditional

K800966 - M.R. ASSOC. CYTOLOGY BRUSHES

K800966 is an FDA 510(k) clearance for M.R. ASSOC. CYTOLOGY BRUSHES, manufactured by Mr Associates, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K800966 · Mr Associates, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1980
Decision
15d
Days
Class 2
Risk

K800966 is an FDA 510(k) clearance for the M.R. ASSOC. CYTOLOGY BRUSHES. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Mr Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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.

FDA 510(k) Submission Details - K800966

510(k) Number K800966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1980
Decision Date May 08, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 131d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDX Device Classification - Class 2, Special Controls

Product Code FDX Endoscopic Cytology Brush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Collect Cells For Cytological Evaluation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDX Endoscopic Cytology Brush

All 39
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K800966.
BARD URETEROSCOPIC CYTOLOGY BRUSH
K844561 · C.R. Bard, Inc. · Jan 1985
GASTROINTESTINAL SHEATH BRUSH
K834402 · Hobbs Medical, Inc. · Feb 1984
MUTO BRUSH
K833330 · Microvasive · Nov 1983
ENDOSCOPIC CYTOLOGY BRUSHES
K791668 · Mill-Rose Laboratory · Oct 1979
UROLOGICAL BIOPSY BRUSH SET
K770913 · Cook, Inc. · Jun 1977