Cleared Traditional

K001600 - CODA INCUBATOR CELLMATE

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

K001600 · Intl., Inc. · Obstetrics & Gynecology device
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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.

View all Intl., Inc. devices

Submission Details

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
22d slower than avg
Panel avg: 160d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K001600.
Geri Embryo Incubator and Geri Dish
K180304 · Genea Biomedx Pty, Ltd. · Apr 2018
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · Cook Urological, Inc. · Oct 1999
COOK MINI-INCUBATOR
K983642 · Cook Ob/Gyn · Feb 1999