Cleared Traditional

K001600 - CODA INCUBATOR CELLMATE

K001600 is an FDA 510(k) clearance for CODA INCUBATOR CELLMATE, manufactured by Intl., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K001600 · Intl., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
182d
Days
Class 2
Risk

K001600 is an FDA 510(k) clearance for the <GENX> CODA INCUBATOR CELLMATE. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Madison, US). The FDA issued a Cleared decision on November 22, 2000 after a review of 182 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 - K001600

510(k) Number K001600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2000
Decision Date November 22, 2000
Days to Decision 182 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
21d slower than avg
Panel avg: 161d · This submission: 182d
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 Consultant

Intl., Inc.
MICHAEL D CECCHI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K001600.
K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
K013401 · K-Systems, Kivex Biotec , Ltd. · Dec 2001
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
K013703 · Sanyo North America Corp. · Dec 2001
MTG - MINITUB HEATED STAGE SYSTEMS
K002971 · Zander Medical Supplies, Inc. · Dec 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
CBS STRAW
K002595 · Cryo Bio System · Nov 2000
K001600 · CODA INCUBATOR CELLMATE
Download PDF Intl., Inc.