Cleared Traditional

K830010 - SUPERJET LANCET

K830010 is the FDA 510(k) clearance for SUPERJET LANCET by Medprobe Laboratories. It is a Class 2 General & Plastic Surgery device (product code FMK) cleared through the Traditional 510(k) pathway .

K830010 · Medprobe Laboratories · General & Plastic Surgery device
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Jan 1983
Decision
-
Days
Class 2
Risk

K830010 is an FDA 510(k) clearance for the SUPERJET LANCET. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Medprobe Laboratories (Walker, US). The FDA issued a Cleared decision on January 26, 1983.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4850 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K830010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1983
Decision Date January 26, 1983
Days to Decision -
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 70
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K830010.
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
K855203 · Miles Laboratories, Inc. · Feb 1986
CHURCHHILL LANCET
K854760 · Churchill Corp. · Jan 1986
STERILE BLOOD LANCETS
K841677 · Abco Dealers, Inc. · Jun 1984
PRICK-TEST NEEDLE
K823760 · Cordis Corp. · Jan 1983
AUTOLANCET
K822209 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1982
MONOJECTOR MONOLET LANCER
K820333 · Sherwood Medical Co. · Mar 1982