Cleared Traditional

K030525 - CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES

K030525 is an FDA 510(k) clearance for CUSTOM PRODUCTS IVF WORKSTATION TYPE WK..., manufactured by Mid-Atlantic Diagnostics, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K030525 · Mid-Atlantic Diagnostics, Inc. · Obstetrics & Gynecology device
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Aug 2003
Decision
189d
Days
Class 2
Risk

K030525 is an FDA 510(k) clearance for the CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST.... Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Mid-Atlantic Diagnostics, Inc. (Marlton, US). The FDA issued a Cleared decision on August 27, 2003 after a review of 189 days - an extended review cycle.

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 - K030525

510(k) Number K030525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date August 27, 2003
Days to Decision 189 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
28d slower than avg
Panel avg: 161d · This submission: 189d
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 K030525.
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K011327 · Zander Medical Supplies, Inc. · Aug 2002
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002
K030525 · CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
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