Cleared Traditional

K991366 - DAUM MRI/CONVENTIONAL BIOPSY KIT

K991366 is an FDA 510(k) clearance for DAUM MRI/CONVENTIONAL BIOPSY KIT, manufactured by Daum GmbH. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K991366 · Daum GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
66d
Days
Class 2
Risk

K991366 is an FDA 510(k) clearance for the DAUM MRI/CONVENTIONAL BIOPSY KIT. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Daum GmbH (Crofton, US). The FDA issued a Cleared decision on June 25, 1999 after a review of 66 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 GmbH devices

FDA 510(k) Submission Details - K991366

510(k) Number K991366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1999
Decision Date June 25, 1999
Days to Decision 66 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
65d faster than avg
Panel avg: 131d · This submission: 66d
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 K991366.
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
GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
K992499 · Gallini U.S., LLC · Aug 1999
FUJI CATHETER, MODEL CTH001
K983867 · Windy Hill Technology, Inc. · Jun 1999
AUTO SUTURE ABBI SYSTEM
K983296 · United States Surgical, A Division of Tyco Healthc · Jun 1999
TRU-CORE I REUSABLE BIOPSY INSTRUMENT
K990839 · Medical Device Technologies, Inc. · May 1999