Cleared Traditional

K253354 - Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (FDA 510(k) Clearance)

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

K253354 · Guangzhou Hehong Biotech Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
135d
Days
Class 2
Risk

K253354 is an FDA 510(k) clearance for the Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20.... Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Guangzhou Hehong Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 12, 2026 after a review of 135 days - within the typical 510(k) review window.

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 Guangzhou Hehong Biotech Co., Ltd. devices

Submission Details

510(k) Number K253354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date February 12, 2026
Days to Decision 135 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
25d faster than avg
Panel avg: 160d · This submission: 135d
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 Peers - MQF Catheter, Assisted Reproduction

All 52
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K253354.
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
Daylily Single Use Sterile Embryo Transfer Catheter
K220010 · Shanghai Horizon Medical Technology Co., Ltd. · Dec 2022