Cleared Traditional

BLOOD LANCET

K850100 · Gainor Medical · General & Plastic Surgery

Jan 1987

Decision

748d

Days

Class 2

Risk

About This 510(k) Submission

K850100 is an FDA 510(k) clearance for the BLOOD LANCET, a Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code FMK), submitted by Gainor Medical. The FDA issued a Cleared decision on January 29, 1987, 748 days after receiving the submission on January 11, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.

Submission Details

510(k) Number	K850100 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1985
Decision Date	January 29, 1987
Days to Decision	748 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4850
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.