Regulator, Vacuum

Device Code: 2618

Product Code(s): KDP

Device Classification Information

• Device Type ID: 2618
• Device Name: Regulator, Vacuum
• Regulation Description: Vacuum-powered Body Fluid Suction Apparatus.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 880.6740 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KDP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized 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

Total Product Life Cycle

• Device Type ID: 2618
• Device: Regulator, Vacuum
• Product Code: KDP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Vacuum-powered Body Fluid Suction Apparatus.
• CFR Regulation Number: 880.6740 [🔎]

Device Problems
Device Operates Differently Than Expected	1
Increase In Suction	1
Suction Problem	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Ohio Medical Corporation	II	Jul-10-2018

TPLC Last Update: 2019-04-02 20:16:15