Cleared Traditional

K002971 - MTG - MINITUB HEATED STAGE SYSTEMS

K002971 is an FDA 510(k) clearance for MTG - MINITUB HEATED STAGE SYSTEMS, manufactured by Zander Medical Supplies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K002971 · Zander Medical Supplies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
84d
Days
Class 2
Risk

K002971 is an FDA 510(k) clearance for the MTG - MINITUB HEATED STAGE SYSTEMS. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Zander Medical Supplies, Inc. (Vero Beach, US). The FDA issued a Cleared decision on December 15, 2000 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002971

510(k) Number K002971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date December 15, 2000
Days to Decision 84 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 161d · This submission: 84d
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 K002971.
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K002971 · MTG - MINITUB HEATED STAGE SYSTEMS
Download PDF FDA Summary Zander Medical Suppli…