Cleared Traditional

K002595 - CBS STRAW

K002595 is an FDA 510(k) clearance for CBS STRAW, manufactured by Cryo Bio System. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K002595 · Cryo Bio System · Obstetrics & Gynecology device
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Nov 2000
Decision
88d
Days
Class 2
Risk

K002595 is an FDA 510(k) clearance for the CBS STRAW. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Cryo Bio System (Irvine, US). The FDA issued a Cleared decision on November 17, 2000 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002595

510(k) Number K002595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date November 17, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 161d · This submission: 88d
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 K002595.
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc. · Nov 2000
MINITUB MULTI-PURPOSE CASSETTES
K002961 · Zander Medical Supplies, Inc. · Nov 2000
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
K003184 · Zander Medical Supplies, Inc. · Nov 2000
KENDRO HERACELL CO2 INCUBATOR
K002805 · Kendro Laboratory Products, L.P. · Nov 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
K001524 · Thermoquest Corp. · Jul 2000
K002595 · CBS STRAW
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