Cleared Traditional

K260194 - Vacuum Pump (Model: AD-VPUM-500)

K260194 is an FDA 510(k) clearance for Vacuum Pump (Model: AD-VPUM-500), manufactured by Sheng Sheng Yi (Beijing) Technology Company Limited. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K260194 · Sheng Sheng Yi (Beijing) Technology Company Limited · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
96d
Days
Class 2
Risk

K260194 is an FDA 510(k) clearance for the Vacuum Pump (Model: AD-VPUM-500). Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Sheng Sheng Yi (Beijing) Technology Company Limited (Beijing, CN). The FDA issued a Cleared decision on April 28, 2026 after a review of 96 days - within the typical 510(k) review window.

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 Sheng Sheng Yi (Beijing) Technology Company Limited devices

FDA 510(k) Submission Details - K260194

510(k) Number K260194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2026
Decision Date April 28, 2026
Days to Decision 96 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
64d faster than avg
Panel avg: 160d · This submission: 96d
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 Peers - MQG Accessory, Assisted Reproduction

All 30
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K260194.
Wallace® Aspiration Pump (WAPV1)
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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
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K180304 · Genea Biomedx Pty, Ltd. · Apr 2018