Cleared Traditional

GM501 Wash (K190383) - FDA 510(k) Clearance

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

K190383 · Hamilton Thorne, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
198d
Days
Class 2
Risk

K190383 is an FDA 510(k) clearance for the GM501 Wash. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Hamilton Thorne, Inc. (Beverly, US). The FDA issued a Cleared decision on September 5, 2019 after a review of 198 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - 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 Hamilton Thorne, Inc. devices

Submission Details

510(k) Number K190383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2019
Decision Date September 05, 2019
Days to Decision 198 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
38d slower than avg
Panel avg: 160d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 50
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K190383.
GM501 SpermAir and GM501 SpermActive
K192644 · Hamilton Thorne Incorporated · Apr 2020
SepaSperm Washing Solution, SepaSperm Solution
K190199 · Kitazato Corporation · Sep 2019
GM501 Mineral Oil
K191552 · Hamilton Thorne, Inc. · Sep 2019
1-Step Culture Medium
K191063 · Shenzhen Vitavitro Biotech Co., Ltd. · Aug 2019
RapidVit™ Oocyte, RapidWarm™ Oocyte
K183486 · Vitrolife Sweden AB · Jul 2019
Vit Kit- Freeze NX and Vit Kit- Warm NX
K190152 · Fujifilm Irvine Scientific, Inc. · Jun 2019