Cleared Traditional

K994272 - AUTOMATED CORE BIOPSY DEVICE

K994272 is an FDA 510(k) clearance for AUTOMATED CORE BIOPSY DEVICE, manufactured by Promex, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K994272 · Promex, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
18d
Days
Class 2
Risk

K994272 is an FDA 510(k) clearance for the AUTOMATED CORE BIOPSY DEVICE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Promex, Inc. (Franklin, US). The FDA issued a Cleared decision on January 7, 2000 after a review of 18 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 Promex, Inc. devices

FDA 510(k) Submission Details - K994272

510(k) Number K994272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1999
Decision Date January 07, 2000
Days to Decision 18 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 131d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

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 304
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K994272.
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · Allegiance Healthcare Corp. · Nov 2000
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
K002546 · CIVCO Medical Instruments Co., Inc. · Oct 2000
BONE BIOPSY NEEDLE
K001132 · Promex, Inc. · May 2000
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE
K993936 · Imagyn Surgical · Dec 1999
DUCPREP BREAST ASPIRATOR, MODEL PMPO2
K993342 · Windy Hill Technology, Inc. · Dec 1999
MANUAL BONE MARROW BIOPSY DEVICE
K993435 · Promex, Inc. · Dec 1999