Cleared Traditional

K200248 - Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators (FDA 510(k) Clearance)

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

K200248 · Allwin Medical Devices, Inc. · Obstetrics & Gynecology device

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Jul 2020

Decision

152d

Days

Class 2

Risk

K200248 is an FDA 510(k) clearance for the Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 1, 2020 after a review of 152 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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.

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Submission Details

510(k) Number	K200248 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 2020
Decision Date	July 01, 2020
Days to Decision	152 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

8d faster than avg

Panel avg: 160d · This submission: 152d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	MQF Catheter, Assisted Reproduction
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 884.6110

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.