Cleared Traditional

Sperm Freeze, Sperm Fridge (K192845) - FDA 510(k) Clearance

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

K192845 · Kitazato Corporation · Obstetrics & Gynecology device
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Aug 2020
Decision
319d
Days
Class 2
Risk

K192845 is an FDA 510(k) clearance for the Sperm Freeze, Sperm Fridge. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Kitazato Corporation (Fuji Shizuoka, JP). The FDA issued a Cleared decision on August 17, 2020 after a review of 319 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. 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. Elevated predicate reliance profile. 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 K192845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2019
Decision Date August 17, 2020
Days to Decision 319 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
159d slower than avg
Panel avg: 160d · This submission: 319d
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
Michael A. Siano

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 K192845.
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
Synvitro Hyadase
K200680 · Origio A/S, A Coopersurgical Company · Jul 2020
GM501 SpermAir and GM501 SpermActive
K192644 · Hamilton Thorne Incorporated · Apr 2020
SepaSperm Washing Solution, SepaSperm Solution
K190199 · Kitazato Corporation · Sep 2019