Product Classification

• Device: device, antichoke, suction
• Definition: Call for PMAs on 7/13/99 per 64 FR 18329 on 4/14/99
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: EWT
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: PMA
• Regulation Number: 874.5350
• Device Class: 3
• 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

• 1-132 ISO 10079-2 Third Edition 2014-05-01
  Medical suction equipment - Part 2: Manually powered suction equipment
• 1-133 ISO 10079-3 Third Edition 2014-05-01
  Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
• 1-142 ISO 10079-1 Third Edition 2015-11-01
  Medical suction equipment - Part 1: Electrically powered suction equipment [Including: Amendment 1 (2018)]
• 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

Third Party Review

Not Third Party Eligible