Cleared Traditional

K032526 - BINDER CO2 INCUBATOR SERIE CB

K032526 is an FDA 510(k) clearance for BINDER CO2 INCUBATOR SERIE CB, manufactured by Binder GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K032526 · Binder GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
14d
Days
Class 2
Risk

K032526 is an FDA 510(k) clearance for the BINDER CO2 INCUBATOR SERIE CB. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Binder GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on August 29, 2003 after a review of 14 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.

View all Binder GmbH devices

FDA 510(k) Submission Details - K032526

510(k) Number K032526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2003
Decision Date August 29, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 160d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 26
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K032526.
PLANER BT37 INCUBATOR
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EMBRYOSCOPE
K111715 · Unisense Fertilitech A/S · Aug 2011
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