Pump, Portable, Aspiration (manual Or Powered)

Device Code: 5485

Product Code(s): BTA

Device Classification Information

• Device Type ID: 5485
• Device Name: Pump, Portable, Aspiration (manual Or Powered)
• Regulation Description: Powered Suction Pump.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: General & Plastic Surgery
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch Two - Surgical (GSDB2)
• Submission Type: 510(k)
• CFR Regulation Number: 878.4780 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: BTA
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 1-131 ISO 10079-1 Third Edition 2015-11-01
  Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment
• 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: 5485
• Device: Pump, Portable, Aspiration (manual Or Powered)
• Product Code: BTA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Powered Suction Pump.
• CFR Regulation Number: 878.4780 [🔎]

Premarket Reviews
Manufacturer	Decision
ATHENA GTX
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDELA
	SUBSTANTIALLY EQUIVALENT	3
MEDELA HOLDING AG
	SUBSTANTIALLY EQUIVALENT	3
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
REX MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	1
SIMEX MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ZOLL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Battery Problem	2
Failure To Run On Battery	2
Failure To Charge	2
Retraction Problem	1
Electrical /Electronic Property Problem	1
Corroded	1
Failure To Osseointegrate	1
Device Operational Issue	1
Device Contamination With Chemical Or Other Material	1
Tube	1
Device Issue	1
Thermal Decomposition Of Device	1
Total Device Problems	15

Recalls
Manufacturer		Recall Class	Date Posted
1	MicroAire Surgical Instruments, LLC	II	Apr-05-2016
2	Ohio Medical Corporation	II	Sep-07-2018

TPLC Last Update: 2019-04-02 21:07:01