Cleared Traditional

K050197 - MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045

K050197 is an FDA 510(k) clearance for MINITUBE TEMPERATURE CONTROL UNIT SC-20..., manufactured by Minitube of America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 617-day FDA review.

K050197 · Minitube of America, Inc. · Obstetrics & Gynecology device
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Oct 2006
Decision
617d
Days
Class 2
Risk

K050197 is an FDA 510(k) clearance for the MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Minitube of America, Inc. (Madison, US). The FDA issued a Cleared decision on October 6, 2006 after a review of 617 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K050197

510(k) Number K050197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date October 06, 2006
Days to Decision 617 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
456d slower than avg
Panel avg: 161d · This submission: 617d
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 K050197.
EMBRYOSCOPE
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HEAL FORCE CO2 INCUBATOR
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K092183 · Unisense Fertilitech A/S · Jan 2011
ZIVF-AIRE
K041952 · Zander Medical Supplies, Inc. · Sep 2005
KRYO ART CONTROLLED RATE FREEZER
K032086 · Planer Plc · Mar 2004
BINDER CO2 INCUBATOR SERIE CB
K032526 · Binder GmbH · Aug 2003
K050197 · MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
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