Cleared Traditional

BIOACCESS BONE BIOPSY SYSTEM (K954151) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954151 · Bioaccess, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
10d
Days
Class 2
Risk

K954151 is an FDA 510(k) clearance for the BIOACCESS BONE BIOPSY SYSTEM. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bioaccess, Inc. (Silver Spring, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Bioaccess, Inc. devices

Submission Details

510(k) Number K954151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date September 15, 1995
Days to Decision 10 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
120d faster than avg
Panel avg: 130d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - KNW Instrument, Biopsy

All 94
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K954151.
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · C.R. Bard, Inc. · Jul 1996
18 GAUGE TRU-CUT BIOPSY NEEDLE
K960509 · Baxter Healthcare Corp · Apr 1996
AUTOMATED TRU-CUT BIOPSY DEVICE
K954529 · Baxter Healthcare Corp · Dec 1995
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE
K935814 · Boston Scientific Corp · Mar 1994
BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.
K922939 · C.R. Bard, Inc. · Feb 1993
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
K910190 · C.R. Bard, Inc. · Aug 1991