Cleared Traditional

CYTOLOGY BRUSH (K922851) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922851 · Annex Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
82d
Days
Class 2
Risk

K922851 is an FDA 510(k) clearance for the CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 25, 1992 after a review of 82 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 Annex Medical, Inc. devices

Submission Details

510(k) Number K922851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date August 25, 1992
Days to Decision 82 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 130d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K922851.
Cytology Brush
K172663 · Micro-Tech (Nanjing) Co., Ltd. · Mar 2018
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
K171573 · Wilson-Cook Medical, Inc. · Dec 2017
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348 · Boston Scientific Corp · Sep 1993
BARD URETEROSCOPIC CYTOLOGY BRUSH
K844561 · C.R. Bard, Inc. · Jan 1985
UROLOGICAL BIOPSY BRUSH SET
K770913 · Cook, Inc. · Jun 1977