Cleared Traditional

K820625 - HEMALET AUTOMATIC LANCET DEVICE

K820625 is the FDA 510(k) clearance for HEMALET AUTOMATIC LANCET DEVICE by Medprobe Laboratories. It is a Class 2 General & Plastic Surgery device (product code FMK) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K820625 · Medprobe Laboratories · General & Plastic Surgery device
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Apr 1982
Decision
32d
Days
Class 2
Risk

K820625 is an FDA 510(k) clearance for the HEMALET AUTOMATIC LANCET DEVICE. 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 (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 32 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medprobe Laboratories devices

Submission Details

510(k) Number K820625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date April 09, 1982
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
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 K820625.
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