Cleared Traditional

K112695 - CRYOTOP (FDA 510(k) Clearance)

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

K112695 · Kitazato Biopharma Co;Ltd · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
454d
Days
Class 2
Risk

K112695 is an FDA 510(k) clearance for the CRYOTOP. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Kitazato Biopharma Co;Ltd (Austin, US). The FDA issued a Cleared decision on December 12, 2012 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6160 - 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: 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 Kitazato Biopharma Co;Ltd devices

Submission Details

510(k) Number K112695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2011
Decision Date December 12, 2012
Days to Decision 454 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
294d slower than avg
Panel avg: 160d · This submission: 454d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQK Labware, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6160
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 - MQK Labware, Assisted Reproduction

All 49
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K112695.
SperSort™ Sperm Sorting Chip (IPG02)
K241626 · Ipreg Incorporation · Feb 2025
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
K241454 · Guangzhou Hehong Biotech Co., Ltd. · Feb 2025
SwimCount® Harvester (1 mL)
K241348 · Motilitycount Aps · Jan 2025
cryo-GO Vitrification Device
K241341 · Fujifilm Irvine Scientific · Sep 2024
G-Vitri™ Vitrification Straw
K240002 · Gimbo Medical Technology Shenzhen Co., Ltd. · Jun 2024
SpermAlign Sperm Separation Device
K232980 · Cytoswim, Ltd. · Mar 2024