Product Classification

• Device: tube, tracheostomy (w/wo connector)
• Regulation Description: Tracheostomy tube and tube cuff.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BTO
• Submission Type: 510(k)
• Regulation Number: 868.5800
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 5366-3:2001 Anaesthetic and Respiratory Equipment -- Tracheostomy Tubes -- Part 3: Pediatric Tracheostomy Tubes TECHNICAL CORRIGENDUM 1
• ISO 5366-3:2001 Second edition 2001-08-15 Anaesthetic and Respiratory Equipment -- Tracheostomy Tubes -- Part 3: Pediatric Tracheostomy Tubes
• ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.