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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drape, surgical, exempt
Regulation Description Surgical drape and drape accessories.
Definition This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePUI
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2021 43 43
2022 47 51
2023 46 46
2024 69 69
2025 55 55
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 133 133
Product Quality Problem 15 15
Contamination 14 14
Material Integrity Problem 13 13
Loss of or Failure to Bond 8 8
Leak/Splash 7 7
Material Perforation 7 7
Material Separation 7 7
Break 6 6
Material Split, Cut or Torn 5 5
No Apparent Adverse Event 5 5
Fluid/Blood Leak 4 4
Flaked 4 4
Material Disintegration 4 4
Patient-Device Incompatibility 4 4
Appropriate Term/Code Not Available 4 4
Delivered as Unsterile Product 4 4
Accessory Incompatible 3 3
Insufficient Information 3 3
Melted 3 3
Material Discolored 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Contamination /Decontamination Problem 2 2
Material Fragmentation 2 2
Packaging Problem 2 2
Failure to Seal 1 1
Loose or Intermittent Connection 1 1
Display or Visual Feedback Problem 1 1
Human-Device Interface Problem 1 1
Nonstandard Device 1 5
Gel Leak 1 1
Fracture 1 1
Detachment of Device or Device Component 1 1
Contamination of Device Ingredient or Reagent 1 1
Misconnection 1 1
Thermal Decomposition of Device 1 1
Component Missing 1 1
Adhesive Too Strong 1 1
Difficult to Remove 1 1
Unsealed Device Packaging 1 1
Difficult to Fold, Unfold or Collapse 1 1
Peeled/Delaminated 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Failure to Eject 1 1
Difficult to Open or Remove Packaging Material 1 1
Entrapment of Device 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 222 226
Insufficient Information 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Post Operative Wound Infection 6 6
Hypersensitivity/Allergic reaction 4 4
Foreign Body Sensation in Eye 3 3
Unspecified Infection 2 2
Rash 2 2
Foreign Body In Patient 2 2
Skin Tears 2 2
Hemorrhage/Bleeding 2 2
Bruise/Contusion 2 2
Skin Inflammation/ Irritation 1 1
Blister 1 1
Itching Sensation 1 1
Abrasion 1 1
Skin Discoloration 1 1
No Patient Involvement 1 1
Pain 1 1
Eye Injury 1 1
Contact Dermatitis 1 1
No Consequences Or Impact To Patient 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Healthcare Business II Nov-18-2022
2 Aesculap Implant Systems LLC II Jul-22-2022
3 Cardinal Health 200, LLC II Jul-08-2021
4 Cardinal Health 200, LLC II Mar-24-2021
5 Ecolab Inc II Feb-22-2021
6 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
7 Medline Industries, LP II Mar-12-2026
8 Medline Industries, LP II Feb-17-2026
9 Microtek Medical Inc. II Jul-28-2023
10 Microtek Medical Inc. II May-12-2022
11 Microtek Medical, Inc. II Jun-12-2025
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