Cleared Traditional

K001486 - GENX CODA AIR PURIFICATION SYSTEM

K001486 is an FDA 510(k) clearance for GENX CODA AIR PURIFICATION SYSTEM, 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 126-day FDA review.

K001486 · Intl., Inc. · Obstetrics & Gynecology device
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Sep 2000
Decision
126d
Days
Class 2
Risk

K001486 is an FDA 510(k) clearance for the GENX CODA AIR PURIFICATION SYSTEM. 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 September 15, 2000 after a review of 126 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K001486

510(k) Number K001486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2000
Decision Date September 15, 2000
Days to Decision 126 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
34d faster than avg
Panel avg: 160d · This submission: 126d
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 30
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K001486.
WORKBENCH BY
K020560 · Intl., Inc. · Jun 2002
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc. · Nov 2000
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
K000394 · Rocket Medical Plc · Feb 2000
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · Cook Urological, Inc. · Oct 1999
HOFFMAN IVF-1
K991216 · (Arms) Hoffman Surgical Equipment, Ivf Division · Aug 1999