Cleared Traditional

K190522 - Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) (FDA 510(k) Clearance)

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

K190522 · Allwin Medical Devices, Inc. · Obstetrics & Gynecology device

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Nov 2019

Decision

255d

Days

Class 2

Risk

K190522 is an FDA 510(k) clearance for the Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip I.... 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 November 14, 2019 after a review of 255 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	K190522 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 04, 2019
Decision Date	November 14, 2019
Days to Decision	255 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

95d slower than avg

Panel avg: 160d · This submission: 255d

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.