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SmartSuction Solo Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062801

by Haemonetics Corp.

Identifiers

510(k) Number
K062801 FDA 510(k)
FDA Product Code
BTA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4780 FDA 510(k)
Regulation Number
878.4780 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SmartSuction Solo Device is a portable, powered aspiration pump designed for general and plastic surgery applications. It functions as a suction source to remove fluids and debris from the surgical field.

It is an AC-powered, stand-alone device intended to replace wall suction in the operating room. The device is supplied as a reusable system and was cleared by the FDA under 510(k) K062801 on October 4, 2006, with product code BTA and regulation number 878.4780.

Frequently asked questions

What is the SmartSuction Solo Device used for?

The SmartSuction Solo Device is a portable, powered aspiration pump designed for general and plastic surgery applications. It functions as a suction source to remove fluids and debris from the surgical field, intended to replace wall suction in the operating room.

Is the SmartSuction Solo Device reusable or single-use?

The SmartSuction Solo Device is supplied as a reusable system, meaning it is designed for multiple uses after appropriate cleaning and reprocessing between procedures, as indicated in its FDA 510(k) clearance documentation.

What power source does the SmartSuction Solo Device require?

The SmartSuction Solo Device is AC-powered and operates as a stand-alone unit, requiring connection to a standard electrical outlet to function as a suction source in the operating room.

When was the SmartSuction Solo Device cleared by the FDA?

The SmartSuction Solo Device was cleared by the FDA under 510(k) K062801 on October 4, 2006, with a determination of substantial equivalence to a legally marketed predicate device.

What regulatory classification and product code apply to the SmartSuction Solo Device?

The SmartSuction Solo Device is classified under product code BTA and regulation number 878.4780, which corresponds to a portable, powered aspiration pump for manual or powered use, as specified in its FDA 510(k) submission.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Haemonetics Launches Automated, Self-Regulating Surgical Suction Device ..., PDF Haemonetics SmartSuction SoloTM OCT -42006, Haemonetics Launches Automated, Self-Regulating Surgical Suction Device ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Haemonetics Corp.

Sources (1)

  • FDA 510(k) K062801 24 fields · synced Sep 25, 2026