Product Classification

• Device: tube, tracheal, reprocessed
• Regulation Description: Tracheal tube.
• Definition: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: NMA
• Premarket Review: Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.5730
• 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?: Yes

Recognized Consensus Standards

• 1-119 ISO 14408 Third edition 2016-02-15
  Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
• 12-323 ISO 11990 Third edition 2018-08
  Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal tube cuffs

Third Party Review

Not Third Party Eligible