Cleared Traditional

SepaSperm Washing Solution, SepaSperm Solution (K190199) - FDA 510(k) Clearance

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

K190199 · Kitazato Corporation · Obstetrics & Gynecology device
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Sep 2019
Decision
234d
Days
Class 2
Risk

K190199 is an FDA 510(k) clearance for the SepaSperm Washing Solution, SepaSperm Solution. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Kitazato Corporation (Fuji-Shi, JP). The FDA issued a Cleared decision on September 26, 2019 after a review of 234 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 Kitazato Corporation devices

Submission Details

510(k) Number K190199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2019
Decision Date September 26, 2019
Days to Decision 234 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
74d slower than avg
Panel avg: 160d · This submission: 234d
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 Consultant

Emergo Global Consulting, LLC
Audrey Swearingen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQL Media, Reproductive

All 50
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K190199.
Sperm Freeze, Sperm Fridge
K192845 · Kitazato Corporation · Aug 2020
Synvitro Hyadase
K200680 · Origio A/S, A Coopersurgical Company · Jul 2020
GM501 SpermAir and GM501 SpermActive
K192644 · Hamilton Thorne Incorporated · Apr 2020
GM501 Mineral Oil
K191552 · Hamilton Thorne, Inc. · Sep 2019
GM501 Wash
K190383 · Hamilton Thorne, Inc. · Sep 2019
1-Step Culture Medium
K191063 · Shenzhen Vitavitro Biotech Co., Ltd. · Aug 2019