Cleared Traditional

K954121 - CYTOLOGY BRUSH

K954121 is an FDA 510(k) clearance for CYTOLOGY BRUSH, manufactured by Lighthouse Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K954121 · Lighthouse Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
36d
Days
Class 2
Risk

K954121 is an FDA 510(k) clearance for the CYTOLOGY BRUSH. Classified as Endoscopic Cytology Brush (product code FDX), Class II - Special Controls.

Submitted by Lighthouse Medical, Inc. (Waltham, US). The FDA issued a Cleared decision on October 7, 1995 after a review of 36 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 Lighthouse Medical, Inc. devices

FDA 510(k) Submission Details - K954121

510(k) Number K954121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date October 07, 1995
Days to Decision 36 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
94d faster than avg
Panel avg: 130d · This submission: 36d
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 26
Devices cleared under the same product code (FDX) and FDA review panel - the closest regulatory comparables to K954121.
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
K040324 · Wilson-Cook Medical, Inc. · May 2004
CELL RECOVERY SYSTEM
K965037 · Medical Device Technologies, Inc. · Jan 1997
CELL RECOVERY SYSTEM
K960004 · Medical Device Technologies, Inc. · Mar 1996
MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
K944614 · Biosearch Medical Products, Inc. · Apr 1995
COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM
K930348 · Boston Scientific Corp · Sep 1993
CYTOLOGY BRUSH
K924104 · United States Endoscopy Group, Inc. · Nov 1992