Cleared Traditional

MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 (K050197) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Minitube of America, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
457d slower than avg
Panel avg: 160d · This submission: 617d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
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