Cleared Traditional

K032086 - KRYO ART CONTROLLED RATE FREEZER

K032086 is an FDA 510(k) clearance for KRYO ART CONTROLLED RATE FREEZER, manufactured by Planer Plc. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K032086 · Planer Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
256d
Days
Class 2
Risk

K032086 is an FDA 510(k) clearance for the KRYO ART CONTROLLED RATE FREEZER. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Planer Plc (Pleasant Hill, US). The FDA issued a Cleared decision on March 19, 2004 after a review of 256 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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.

FDA 510(k) Submission Details - K032086

510(k) Number K032086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date March 19, 2004
Days to Decision 256 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
95d slower than avg
Panel avg: 161d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 46
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K032086.
EMBRYOSCOPE AND EMBRYOSLIDE
K092183 · Unisense Fertilitech A/S · Jan 2011
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
K050197 · Minitube of America, Inc. · Oct 2006
ZIVF-AIRE
K041952 · Zander Medical Supplies, Inc. · Sep 2005
BINDER CO2 INCUBATOR SERIE CB
K032526 · Binder GmbH · Aug 2003
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES
K030525 · Mid-Atlantic Diagnostics, Inc. · Aug 2003
KENDRO HERACELL 240 INCUBATOR
K023465 · Kendro Laboratory Products, L.P. · Mar 2003
K032086 · KRYO ART CONTROLLED RATE FREEZER
Download PDF FDA Summary Planer Plc