Cleared Traditional

K112695 - CRYOTOP

K112695 is an FDA 510(k) clearance for CRYOTOP, manufactured by Kitazato Biopharma Co;Ltd. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K112695 · Kitazato Biopharma Co;Ltd · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K112695

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 161d · This submission: 454d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQK Device Classification - Class 2, Special Controls

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
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