Cleared Traditional

K092398 - HSV STRAW

K092398 is an FDA 510(k) clearance for HSV STRAW, manufactured by Cryo Bio System. The device is a Class 2 Obstetrics & Gynecology device with product code MQK cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K092398 · Cryo Bio System · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
426d
Days
Class 2
Risk

K092398 is an FDA 510(k) clearance for the HSV STRAW. Classified as Labware, Assisted Reproduction (product code MQK), Class II - Special Controls.

Submitted by Cryo Bio System (Mission Viejo, US). The FDA issued a Cleared decision on October 6, 2010 after a review of 426 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 - K092398

510(k) Number K092398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2009
Decision Date October 06, 2010
Days to Decision 426 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
265d slower than avg
Panel avg: 161d · This submission: 426d
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
Devices cleared under the same product code (MQK) and FDA review panel - the closest regulatory comparables to K092398.
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
K112413 · Research Instruments , Ltd. · Jul 2012
EEVATM PETRI DISH
K103028 · Auxogyn, Inc. · Aug 2011
CRYOPETTE
K100596 · Mid-Atlantic Diagnostics, Inc. · Dec 2010
RAPID-I
K090832 · Vitrolife Sweden AB · Dec 2009
NUNC IVF CENTERWELL AND ICSI DISHES
K090429 · Thermo Fisher Scientific (Nalge Nunc Intl) · Sep 2009
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
K081896 · Biogenics, Inc. · Aug 2008
K092398 · HSV STRAW
Download PDF FDA Summary Cryo Bio System