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Binder CO2 Incubator Serie CB

by Binder GmbH

510(k) K032526

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032526 Date29 Aug 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQG
Device Class
Class II
Regulation
21 CFR Part 884.6120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CO2 Incubator Serie CB is a laboratory device designed for cell-based assays in drug and medical research. It features a seamless stainless steel inner chamber with flanges as a shelf support system and provides condensation-free humidity control with Permadry double technology. The incubator is suitable for complex cultivation experiments and can be used in individual environments with hypoxic conditions.

The device is equipped with hot air sterilization at +180°C and a hot air sterilizable CO2 sensor using single-beam infrared technology. It is supplied in various models including CB 260 and CB 56. The device has received FDA 510K clearance and is classified as a Class II medical device with product code MQG, intended for use in Obstetrics/Gynecology applications.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BINDER CO2 Incubator Serie CB used for?

    The CO2 Incubator Serie CB is designed for cell-based assays in drug and medical research, suitable for complex cultivation experiments and use in individual environments with hypoxic conditions.

  • What are the key features of the BINDER CO2 Incubator Serie CB?

    The device features a seamless stainless steel inner chamber with flanges as a shelf support system, condensation-free humidity control with Permadry double technology, and hot air sterilization at +180°C with a hot air sterilizable CO2 sensor using single-beam infrared technology.

  • What models are available for the BINDER CO2 Incubator Serie CB?

    The device is supplied in various models including CB 260 and CB 56, each designed to meet different laboratory requirements while maintaining the same core functionality and features.

  • What is the regulatory classification of the BINDER CO2 Incubator Serie CB?

    The device has received FDA 510K clearance and is classified as a Class II medical device with product code MQG, intended for use in Obstetrics/Gynecology applications.