ASA01 Heavy Duty Suction Pump

510(k) Number

K071607 ↗

FDA Product Code

BTA

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the ASA01 Heavy Duty Suction Pump used for?

  The ASA01 Heavy Duty Suction Pump is designed to remove bodily fluids—such as secretions, blood, or other liquids—from a patient’s airway or respiratory support system. This ensures clear airflow and supports effective respiratory care during clinical procedures, particularly in surgical or intensive care settings. It is intended for use by trained personnel under physician supervision.

• Is the ASA01 Heavy Duty Suction Pump reusable or single-use?

  The ASA01 Heavy Duty Suction Pump is explicitly supplied as a reusable device. It is powered by AC electricity and is not intended for single-use applications. Reusability is a key feature, allowing for cost-effective use in clinical environments where multiple procedures may require suctioning.

• What are the key specifications or distinguishing features of this suction pump?

  The ASA01 is classified as a Class II medical device and operates using a vacuum mechanism to evacuate fluids efficiently. It is portable, AC-powered, and designed for heavy-duty use in clinical settings. The device falls under FDA product code BTA and was granted 510(k) clearance (K071607) with a determination of substantial equivalence. No specific sterility or MRI safety requirements are noted in the regulatory data.

• How is the ASA01 Heavy Duty Suction Pump regulated?

  The ASA01 Heavy Duty Suction Pump is regulated under the FDA’s 510(k) clearance process, with clearance number K071607. It was classified under the product code BTA and reviewed by the Surgical Devices Panel (SU) of the General and Plastic Surgery advisory committee. The device was determined to be substantially equivalent to a predicate device, ensuring compliance with FDA standards for safety and effectiveness.

• What clinical settings or procedures benefit most from this suction pump?

  The ASA01 Heavy Duty Suction Pump is particularly useful in clinical settings where airway clearance is critical, such as operating rooms, emergency departments, and intensive care units. It supports procedures like endotracheal intubation, bronchoscopy, or postoperative care by efficiently removing fluids that could obstruct breathing or compromise respiratory function. Its heavy-duty design ensures reliability during prolonged or high-demand use.