Cleared Traditional

K954264 - ACI SINGLE LUMEN BIOPSY NEEDLE

K954264 is an FDA 510(k) clearance for ACI SINGLE LUMEN BIOPSY NEEDLE, manufactured by Advanced Cytometrix, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K954264 · Advanced Cytometrix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Nov 1995
Decision
78d
Days
Class 2
Risk

K954264 is an FDA 510(k) clearance for the ACI SINGLE LUMEN BIOPSY NEEDLE. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Advanced Cytometrix, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 Advanced Cytometrix, Inc. devices

FDA 510(k) Submission Details - K954264

510(k) Number K954264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1995
Decision Date November 29, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 108
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K954264.
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