Cleared Traditional

K240307 - VitaVitro Embryo Transfer Catheter (Mod...

K240307 is an FDA 510(k) clearance for VitaVitro Embryo Transfer Catheter (Mod..., manufactured by Shenzhen Vitavitro Biotech Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K240307 · Shenzhen Vitavitro Biotech Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
196d
Days
Class 2
Risk

K240307 is an FDA 510(k) clearance for the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH). Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 16, 2024 after a review of 196 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 Shenzhen Vitavitro Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K240307

510(k) Number K240307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date August 16, 2024
Days to Decision 196 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
36d slower than avg
Panel avg: 160d · This submission: 196d
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 K240307.
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
K253354 · Guangzhou Hehong Biotech Co., Ltd. · Feb 2026
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500)
K243373 · Vitrolife Sweden AB · Jul 2025
FemaSeed Intratubal Insemination
K231730 · Femasys, Inc. · Sep 2023
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