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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device single use only blood lancet with an integral sharps injury prevention feature
Regulation Description Blood lancets.
Definition A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Product CodeFMK
Regulation Number 878.4850
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCRIVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI POLYSLIDER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DRAWBRIDGE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FACET TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
GRI-ALLESET, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEBEI XINLE SCI&TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HLB CO., LTD. HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HTL-STREFA S.A
  SUBSTANTIALLY EQUIVALENT 1
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIFUN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDIPURPOSE PTE. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO CAREMED MEDICAL PRODUCTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO MEDSUN MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
NSP TECH PTE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
OWEN MUMFORD, LTD.
  SUBSTANTIALLY EQUIVALENT 5
PRIVAPATH DIAGNOSTICS LTD (DBA LETSGETCHECKED)
  SE - WITH LIMITATIONS 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
REDDROP DX
  SE - WITH LIMITATIONS 1
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 4
SARSTEDT AG & CO KG
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG LIANFA MEDICAL PLASTIC PRODUCTS CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERILANCE MEDICAL (SUZHOU), INC.
  SUBSTANTIALLY EQUIVALENT 4
SUZHOU KYUAN MEDICAL APPARATUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ZHENWU MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TASSO, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN HUAHONG TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
TIANJIN RILIFINE MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YOURBIO HEALTH, INC.
  SE - WITH LIMITATIONS 1

MDR Year MDR Reports MDR Events
2021 245 245
2022 254 255
2023 282 282
2024 243 243
2025 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Retraction Problem 779 779
Break 21 21
Device Contamination with Chemical or Other Material 20 20
Product Quality Problem 18 18
Defective Component 17 17
Failure to Fire 16 16
Material Fragmentation 16 16
Defective Device 16 16
Detachment of Device or Device Component 14 14
Unable to Obtain Readings 14 14
Difficult or Delayed Activation 13 13
Delivered as Unsterile Product 12 12
Device Markings/Labelling Problem 12 12
Insufficient Information 12 12
Material Twisted/Bent 10 10
Appropriate Term/Code Not Available 9 9
Component Missing 9 9
Material Separation 8 8
Fail-Safe Did Not Operate 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Missing Information 6 6
Separation Problem 6 6
Material Protrusion/Extrusion 5 5
Material Deformation 5 5
Device Damaged Prior to Use 4 4
Firing Problem 4 4
Ejection Problem 4 4
Mechanical Problem 4 4
Premature Separation 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Protective Measures Problem 3 3
Activation, Positioning or Separation Problem 3 3
Crack 3 3
Physical Resistance/Sticking 3 3
Packaging Problem 3 3
Mechanical Jam 2 2
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Contamination with Body Fluid 2 2
Sharp Edges 2 2
Contamination /Decontamination Problem 2 2
Separation Failure 2 2
Insufficient Flow or Under Infusion 1 1
Solder Joint Fracture 1 1
Device Difficult to Maintain 1 1
Output Problem 1 1
Improper Flow or Infusion 1 1
Failure to Eject 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 887 888
No Consequences Or Impact To Patient 42 42
Needle Stick/Puncture 42 42
Hypoglycemia 15 15
Insufficient Information 15 15
Loss of consciousness 14 14
Dizziness 9 9
Shaking/Tremors 8 8
Hyperglycemia 8 8
Convulsion/Seizure 7 7
Device Embedded In Tissue or Plaque 6 6
Fatigue 6 6
Skin Inflammation/ Irritation 6 6
Pain 6 6
Laceration(s) 6 6
Skin Infection 5 5
Headache 5 5
Diaphoresis 5 5
Exposure to Body Fluids 5 5
Swelling/ Edema 4 4
Foreign Body In Patient 4 4
Unspecified Tissue Injury 3 3
Anxiety 2 2
Alteration in Body Temperature 2 2
Rash 2 2
Confusion/ Disorientation 2 2
Muscle Weakness 2 2
Syncope/Fainting 2 2
Dysphasia 2 2
Nerve Damage 1 1
Hepatitis 1 1
Dyspnea 1 1
Fall 1 1
Abrasion 1 1
Diabetic Ketoacidosis 1 1
Unspecified Gastrointestinal Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Polydipsia 1 1
Contact Dermatitis 1 1
Injection Site Reaction 1 1
Impaired Healing 1 1
Unspecified Infection 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Lethargy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health Inc. II Jun-23-2021
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