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510(k) Data Aggregation
K Number
K234081Device Name
RedDrop ONE (One)
Manufacturer
Date Cleared
2024-03-21
(90 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
RedDrop Dx
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RedDrop ONE is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
Device Description
The RedDrop ONE Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The device is adhered to the skin in the selected position on the upper arm. The device is actuated by sliding the actuator causing an energized spring to release and deploy the lancet array. The lancet array is deployed to a maximum depth of 2 mm to access capillaries. The lancet array is then automatically retracted to a safe position that prevents sharps injury and re-activation. Sliding the actuator also releases two spring loaded pistons that create a gentle vacuum to the skin to facilitate the emergence of capillary blood from the sample site.
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