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Recirculation Filter Model RF-10

by Bentley Laboratories, Inc.

510(k) K790361

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790361 Date28 Mar 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
KRJ
Device Class
Class II
Regulation
21 CFR Part 870.4280
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Recirculation Filter Model Rf-10 is a filter, prebypass, cardiopulmonary bypass device. It is classified as a class 2 device. The device is used in cardiovascular applications.

The device is supplied by Bentley Laboratories, Inc. and has FDA 510K authorization. It is registered with the FDA under the product code KRJ and has the regulation number 870.4280. The device has been cleared by the FDA with the decision code SESE.

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See all devices from Bentley Laboratories, Inc. →

Questions

AI-generated answers, 26 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 Recirculation Filter Model RF-10 used for?

    The Recirculation Filter Model RF-10 is used in cardiovascular applications as a prebypass cardiopulmonary bypass filter, helping to filter blood during bypass procedures.

  • Is the Recirculation Filter Model RF-10 supplied sterile?

    The device data does not specify if the Recirculation Filter Model RF-10 is supplied sterile, it is recommended to consult the manufacturer's instructions for use.

  • What is the regulatory classification of the Recirculation Filter Model RF-10?

    The Recirculation Filter Model RF-10 is classified as a class 2 device with the regulation number 870.4280 and has been cleared by the FDA with the decision code SESE.