Cleared Traditional

K190522 - Allwin Intra Uterine Insemination Cathe...

K190522 is an FDA 510(k) clearance for Allwin Intra Uterine Insemination Cathe..., manufactured by Allwin Medical Devices, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K190522 · Allwin Medical Devices, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Allwin Medical Devices, Inc. devices

FDA 510(k) Submission Details - K190522

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
Combination Product No
PCCP Authorized No
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.

MQF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MQF Catheter, Assisted Reproduction

All 24
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K190522.
Daylily Single Use Sterile Embryo Transfer Catheter
K220010 · Shanghai Horizon Medical Technology Co., Ltd. · Dec 2022
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K200248 · Allwin Medical Devices, Inc. · Jul 2020
Kitazato ET Catheters
K192540 · Kitazato Corporation · May 2020
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
K191015 · Cook Incorporated · May 2019
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
K180302 · Cook Incorporated · Oct 2018
Towako Transmyometrial Embryo Transfer Set
K173431 · William A. Cook Australia Pty. , Ltd. · May 2018