Cleared Traditional

K232493 - Embryo Real-time Incubator (TLS301)

K232493 is an FDA 510(k) clearance for Embryo Real-time Incubator (TLS301), manufactured by Wuhan Huchuang Union Technology Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K232493 · Wuhan Huchuang Union Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
264d
Days
Class 2
Risk

K232493 is an FDA 510(k) clearance for the Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004). Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Wuhan Huchuang Union Technology Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on May 7, 2024 after a review of 264 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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 Wuhan Huchuang Union Technology Co., Ltd. devices

FDA 510(k) Submission Details - K232493

510(k) Number K232493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2023
Decision Date May 07, 2024
Days to Decision 264 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
104d slower than avg
Panel avg: 160d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

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 - MQG Accessory, Assisted Reproduction

All 12
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K232493.
Vacuum Pump (Model: AD-VPUM-500)
K260194 · Sheng Sheng Yi (Beijing) Technology Company Limited · Apr 2026
Harioculture TL-16 Time-lapse Incubator
K242684 · Hua Yue Medical Technology Co., Ltd. · May 2025
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
K180188 · Genea Biomedx Pty, Ltd. · Jun 2018
EmbryoScope+
K173264 · Vitrolife A/S · May 2018
Geri Embryo Incubator and Geri Dish
K180304 · Genea Biomedx Pty, Ltd. · Apr 2018
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002