Product Classification

• Device: pump, portable, aspiration (manual or powered)
• Regulation Description: Powered suction pump.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Product Code: BTA
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4780
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 1-155 ISO 10079-2 Fourth edition 2022-03
  Medical suction equipment - Part 2: Manually powered suction equipment
• 1-156 ISO 10079-3 Fourth edition 2022-03
  Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
• 1-157 ISO 10079-1 Fourth edition 2022-03
  Medical suction equipment - Part 1: Electrically powered suction equipment
• 1-158 ISO 10079-4 First edition 2021-08
  Medical suction equipment - Part 4: General requirements

Guidance Document

• Guidance Document for Powered Suction Pump 510(k)s

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc