Cleared Traditional

K981320 - DAUM BONE BIOPSY SET

K981320 is an FDA 510(k) clearance for DAUM BONE BIOPSY SET, manufactured by Daum Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K981320 · Daum Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
80d
Days
Class 2
Risk

K981320 is an FDA 510(k) clearance for the DAUM BONE BIOPSY SET. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Daum Corp. (Clarence, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 80 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 Daum Corp. devices

FDA 510(k) Submission Details - K981320

510(k) Number K981320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date June 29, 1998
Days to Decision 80 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
50d faster than avg
Panel avg: 130d · This submission: 80d
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 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K981320.
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · Medical Device Technologies, Inc. · May 1999
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
K982960 · Medical Device Technologies, Inc. · Sep 1998
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT
K982085 · Medical Device Technologies, Inc. · Jul 1998
PUNCTURENEEDLE
K963794 · Ferguson Medical · Mar 1998
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
K980226 · Medical Device Technologies, Inc. · Feb 1998
MANAN LIVER BIOPSY KIT
K980452 · Medical Device Technologies, Inc. · Feb 1998