Cleared Traditional

SureStrip Vitrification Straw, SureLock Vitrification Straw (K203626) - FDA 510(k) Clearance

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

K203626 · Allwin Medical Devices, Inc. · Obstetrics & Gynecology device
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Jun 2021
Decision
175d
Days
Class 2
Risk

K203626 is an FDA 510(k) clearance for the SureStrip Vitrification Straw, SureLock Vitrification Straw. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 4, 2021 after a review of 175 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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.

View all Allwin Medical Devices, Inc. devices

Submission Details

510(k) Number K203626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2020
Decision Date June 04, 2021
Days to Decision 175 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
15d slower than avg
Panel avg: 160d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 - MQK Labware, Assisted Reproduction

All 16
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K203626.
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EmbryoSlide+ ic8 dish
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Rapid-i™ Kit
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