Cleared Traditional

K160504 - RI Witness Embryology Heated Plate (FDA 510(k) Clearance)

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

K160504 · Research Instruments Limited · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
145d
Days
Class 2
Risk

K160504 is an FDA 510(k) clearance for the RI Witness Embryology Heated Plate. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Research Instruments Limited (Falmouth, GB). The FDA issued a Cleared decision on July 18, 2016 after a review of 145 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 Research Instruments Limited devices

Submission Details

510(k) Number K160504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2016
Decision Date July 18, 2016
Days to Decision 145 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 160d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K160504.
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
Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
K232493 · Wuhan Huchuang Union Technology Co., Ltd. · May 2024