Cleared Traditional

K823760 - PRICK-TEST NEEDLE

K823760 is an FDA 510(k) clearance for PRICK-TEST NEEDLE, manufactured by Cordis Corp.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K823760 · Cordis Corp. · General & Plastic Surgery device
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Jan 1983
Decision
31d
Days
Class 2
Risk

K823760 is an FDA 510(k) clearance for the PRICK-TEST NEEDLE. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Cordis Corp. (Walker, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 31 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 Cordis Corp. devices

FDA 510(k) Submission Details - K823760

510(k) Number K823760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date January 14, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMK Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K823760.
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
AUTOLANCET
K822209 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1982
MONOJECTOR MONOLET LANCER
K820333 · Sherwood Medical Co. · Mar 1982