Cleared Traditional

K151357 - MIRI TL

K151357 is an FDA 510(k) clearance for MIRI TL, manufactured by At Medical Uab. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K151357 · At Medical Uab · Obstetrics & Gynecology device
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Apr 2016
Decision
338d
Days
Class 2
Risk

K151357 is an FDA 510(k) clearance for the MIRI TL. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by At Medical Uab (Kaunas, LT). The FDA issued a Cleared decision on April 22, 2016 after a review of 338 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K151357

510(k) Number K151357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2015
Decision Date April 22, 2016
Days to Decision 338 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
177d slower than avg
Panel avg: 161d · This submission: 338d
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 K151357.
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K133742 · At Medical Uab · Apr 2014