Cleared Special

K192503 - GM501 Wash with Phenol Red and Gentamicin

K192503 is the FDA 510(k) clearance for GM501 Wash with Phenol Red and Gentamicin by Hamilton Thorne Incorporated. It is a Class 2 Obstetrics & Gynecology device (product code MQL) cleared through the Special 510(k) pathway after a 434-day FDA review.

K192503 · Hamilton Thorne Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
434d
Days
Class 2
Risk

K192503 is an FDA 510(k) clearance for the GM501 Wash with Phenol Red and Gentamicin. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Hamilton Thorne Incorporated (Beverly, US). The FDA issued a Cleared decision on November 19, 2020 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Hamilton Thorne Incorporated devices

Submission Details

510(k) Number K192503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2019
Decision Date November 19, 2020
Days to Decision 434 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
274d slower than avg
Panel avg: 160d · This submission: 434d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 - MQL Media, Reproductive

All 121
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K192503.
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
K212410 · Shenzhen Vitavitro Biotech Co., Ltd. · Feb 2022
Gx-IVF, Gx-TL, Gx-MOPS PLUS
K202862 · Vitrolife Sweden AB · May 2021
V-ONESTEP
K193285 · Vitromed GmbH · Nov 2020
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
K200249 · Kitazato Corporation · Oct 2020
VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium
K200408 · Shenzhen Vitavitro Biotech Co., Ltd. · Oct 2020
iMedium Single Step
K193522 · Kitazato Corporation · Aug 2020