Cleared Traditional

K020560 - WORKBENCH BY

K020560 is an FDA 510(k) clearance for WORKBENCH BY , manufactured by Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K020560 · Intl., Inc. · Obstetrics & Gynecology device
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Jun 2002
Decision
119d
Days
Class 2
Risk

K020560 is an FDA 510(k) clearance for the WORKBENCH BY <GENX>. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Gilford, US). The FDA issued a Cleared decision on June 19, 2002 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K020560

510(k) Number K020560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2002
Decision Date June 19, 2002
Days to Decision 119 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 161d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQG Accessory, Assisted Reproduction

All 46
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K020560.
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
K030525 · Mid-Atlantic Diagnostics, Inc. · Aug 2003
KENDRO HERACELL 240 INCUBATOR
K023465 · Kendro Laboratory Products, L.P. · Mar 2003
DB1 EMBRYO FREEZE
K011327 · Zander Medical Supplies, Inc. · Aug 2002
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS
K021042 · Thermo Forma, Inc. · May 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
K013401 · K-Systems, Kivex Biotec , Ltd. · Dec 2001
K020560 · WORKBENCH BY
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