Cleared Traditional

Daylily Single Use Sterile Embryo Transfer Catheter (K220010) - FDA 510(k) Clearance

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

K220010 · Shanghai Horizon Medical Technology Co., Ltd. · Obstetrics & Gynecology device
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Dec 2022
Decision
346d
Days
Class 2
Risk

K220010 is an FDA 510(k) clearance for the Daylily Single Use Sterile Embryo Transfer Catheter. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Shanghai Horizon Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 16, 2022 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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

View all Shanghai Horizon Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K220010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2022
Decision Date December 16, 2022
Days to Decision 346 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 160d · This submission: 346d
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.

Regulatory Consultant

Microport Group Co., Ltd.
Zhixuan Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQF Catheter, Assisted Reproduction

All 15
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K220010.
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500)
K243373 · Vitrolife Sweden AB · Jul 2025
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
K240307 · Shenzhen Vitavitro Biotech Co., Ltd. · Aug 2024
FemaSeed Intratubal Insemination
K231730 · Femasys, Inc. · Sep 2023
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
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)
K190522 · Allwin Medical Devices, Inc. · Nov 2019