Cleared Traditional

K993342 - DUCPREP BREAST ASPIRATOR, MODEL PMPO2

K993342 is an FDA 510(k) clearance for DUCPREP BREAST ASPIRATOR, manufactured by Windy Hill Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K993342 · Windy Hill Technology, Inc. · Gastroenterology & Urology device
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Dec 1999
Decision
79d
Days
Class 2
Risk

K993342 is an FDA 510(k) clearance for the DUCPREP BREAST ASPIRATOR, MODEL PMPO2. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Windy Hill Technology, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 23, 1999 after a review of 79 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 Windy Hill Technology, Inc. devices

FDA 510(k) Submission Details - K993342

510(k) Number K993342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1999
Decision Date December 23, 1999
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 131d · This submission: 79d
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 306
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K993342.
BONE BIOPSY NEEDLE
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AUTOMATED CORE BIOPSY DEVICE
K994272 · Promex, Inc. · Jan 2000
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE
K993936 · Imagyn Surgical · Dec 1999
MANUAL BONE MARROW BIOPSY DEVICE
K993435 · Promex, Inc. · Dec 1999
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
K992813 · Ethicon Endo-Surgery, Inc. · Nov 1999
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
K991980 · Ethicon Endo-Surgery, Inc. · Aug 1999