Cleared Traditional

NEOSCI MEDICAL ENDOLUMINAL BRUSH (K030400) - FDA 510(k) Clearance

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

K030400 · Neosci Medical, Inc. · General Hospital
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Dec 2004
Decision
685d
Days
Class 2
Risk

K030400 is an FDA 510(k) clearance for the NEOSCI MEDICAL ENDOLUMINAL BRUSH. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Neosci Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 685 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Neosci Medical, Inc. devices

Submission Details

510(k) Number K030400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2003
Decision Date December 22, 2004
Days to Decision 685 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
556d slower than avg
Panel avg: 129d · This submission: 685d
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 79
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K030400.
6 FR DL POWERPICC CATHETER
K050931 · C.R. Bard, Inc. · Jun 2005
POWERHOHN AND POWERLINE CATHETERS
K050185 · C.R. Bard, Inc. · May 2005
6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC
K043502 · C.R. Bard, Inc. · Jan 2005
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
K042491 · Becton, Dickinson & CO · Nov 2004
TRIFUSION, MODEL 0609190/0659350
K041088 · C.R. Bard, Inc. · Nov 2004
POWERPICC CATHETERS, MODELS 3175155, 3175135
K033389 · C.R. Bard, Inc. · Mar 2004