TPLC - Total Product Life Cycle

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Device	blood pressure cuff
Regulation Description	Blood pressure cuff.
Definition	A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Product Code	DXQ
Regulation Number	870.1120
Device Class	2

Premarket Reviews
Manufacturer	Decision
AVITA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CARDICARE COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI CAREMATE MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN BEST ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CORERAY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MEDKE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PLINMA TECHNOLOGY CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNIMED MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU LONGWAN MEDICAL DEVICE FACTORY
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUXI EXANOVO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG LUDE TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	9	9
Manufacturing, Packaging or Shipping Problem	5	5
Pressure Problem	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Appropriate Term/Code Not Available	3	3
Peeled/Delaminated	3	3
Unable to Obtain Readings	3	3
Material Separation	3	3
Unraveled Material	3	3
Biocompatibility	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Gas/Air Leak	2	2
Material Integrity Problem	2	2
No Flow	1	1
Material Deformation	1	1
No Pressure	1	1
Insufficient Information	1	1
Patient Device Interaction Problem	1	1
Unexpected Shutdown	1	1
Air/Gas in Device	1	1
Failure to Read Input Signal	1	1
Break	1	1
Material Discolored	1	1
Display or Visual Feedback Problem	1	1
Inflation Problem	1	1
Overheating of Device	1	1
Calibration Problem	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Electrical Power Problem	1	1
Low Readings	1	1
Defective Device	1	1
Battery Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	48	48
Insufficient Information	11	11
Bruise/Contusion	4	4
Pain	2	2
Contact Dermatitis	2	2
Caustic/Chemical Burns	2	2
Superficial (First Degree) Burn	1	1
Skin Infection	1	1
Skin Inflammation/ Irritation	1	1
Myalgia	1	1
Skin Discoloration	1	1
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Rash	1	1
Needle Stick/Puncture	1	1
Loss of Range of Motion	1	1
Viral Infection	1	1
Eye Injury	1	1
Muscle/Tendon Damage	1	1
Tachycardia	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Cerebrospinal Fluid Leakage	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Dec-01-2025
2	Baxter Healthcare Corporation	II	Apr-15-2025
3	GE Medical Systems Information Technologies Inc	II	Jun-06-2024
4	Volcano Corp	II	Jun-16-2022