Cleared Traditional

K853530 - ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH

K853530 is an FDA 510(k) clearance for ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY..., manufactured by E-Z-Em, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K853530 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Oct 1985
Decision
42d
Days
Class 2
Risk

K853530 is an FDA 510(k) clearance for the ENDO DYNAMICS GASTROINTESTINAL CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 42 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.

View all E-Z-Em, Inc. devices

FDA 510(k) Submission Details - K853530

510(k) Number K853530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1985
Decision Date October 04, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 131d · This submission: 42d
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 36
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K853530.
HOBBS MEDICAL MICROBIOLOGY BRUSH
K893729 · Hobbs Medical, Inc. · Aug 1989
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095 · Van-Tec, Inc. · Mar 1988
GASTROINTESTINAL CYTOLOGY BRUSH
K860997 · Endovations · May 1986
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