Cleared Traditional

FAS ENDOLUMINAL BRUSH (K012641) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012641 · Fas Medical , Ltd. · General Hospital
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Oct 2001
Decision
63d
Days
Class 2
Risk

K012641 is an FDA 510(k) clearance for the FAS ENDOLUMINAL BRUSH. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Fas Medical , Ltd. (Indian Hills, US). The FDA issued a Cleared decision on October 15, 2001 after a review of 63 days - a notably fast clearance cycle.

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: 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 Fas Medical , Ltd. devices

Submission Details

510(k) Number K012641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date October 15, 2001
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K012641.
POLY PER-Q-CATH PICC CATHETERS
K031129 · C.R. Bard, Inc. · May 2003
SILICONE DUAL LUMEN RADPICC CATHETERS
K030255 · C.R. Bard, Inc. · Feb 2003
GROSHONG NXT DUAL LUMEN PICC CATHETERS
K023374 · C.R. Bard, Inc. · Dec 2002
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · C.R. Bard, Inc. · Sep 2001
CENTRAL VENOUS CATHETER
K003839 · Boston Scientific Corp · Aug 2001
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
K001901 · C.R. Bard, Inc. · Sep 2000