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SARNS Ultrasonic Air Sensor

by 3M Health Care, Sarns

510(k) K940651

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 NumberK940651 Date24 May 1994ClearedStatusActive

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  • Withdrawn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
KRL
Device Class
Class II
Regulation
21 CFR Part 870.4205
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 SARNS Ultrasonic Air Sensor is a cardiopulmonary bypass bubble detector used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit. This device is designed to enhance patient safety during cardiovascular procedures by identifying air emboli in real-time.

The SARNS Ultrasonic Air Sensor is supplied as a single-use device and is not MRI compatible. It is regulated under FDA 510(k) clearance with product code KRL and was cleared on May 24, 1994, as substantially equivalent to predicate devices. The device is manufactured by 3M Health Care, Sarns and is classified under regulation number 870.4205.

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Questions

AI-generated answers, 28 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 Sarns Ultrasonic Air Sensor used for?

    The Sarns Ultrasonic Air Sensor is used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit, enhancing patient safety during cardiovascular procedures.

  • Is the Sarns Ultrasonic Air Sensor reusable?

    No, the Sarns Ultrasonic Air Sensor is supplied as a single-use device.

  • Is the Sarns Ultrasonic Air Sensor compatible with MRI machines?

    No, the Sarns Ultrasonic Air Sensor is not MRI compatible.