Cleared Traditional

K050889 - FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH

K050889 is an FDA 510(k) clearance for FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH, manufactured by Crs Medical Diagnostics, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K050889 · Crs Medical Diagnostics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
142d
Days
Class 2
Risk

K050889 is an FDA 510(k) clearance for the FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Crs Medical Diagnostics, Inc. (Pewaukee, US). The FDA issued a Cleared decision on August 26, 2005 after a review of 142 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Crs Medical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K050889

510(k) Number K050889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2005
Decision Date August 26, 2005
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 219
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K050889.
POWERPICC
K053501 · Bard Access Systems, Inc. · Jan 2006
POWERPICC
K051672 · Bard Access Systems, Inc. · Nov 2005
POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE
K051991 · C.R. Bard, Inc. · Oct 2005
VYGON NUTRILINE CATHETERS
K051690 · Vygon Corp. · Aug 2005
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669
K051194 · Becton, Dickinson & CO · Jul 2005
TURBO-FLO PICC
K041849 · Cook, Inc. · Jul 2005