Cleared Special

GM501 Wash with Phenol Red and Gentamicin (K192503) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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 258
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