Cleared Traditional

K850100 - BLOOD LANCET

K850100 is the FDA 510(k) clearance for BLOOD LANCET by Gainor Medical. It is a Class 2 General & Plastic Surgery device (product code FMK) cleared through the Traditional 510(k) pathway after a 748-day FDA review.

K850100 · Gainor Medical · General & Plastic Surgery device
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Jan 1987
Decision
748d
Days
Class 2
Risk

K850100 is an FDA 510(k) clearance for the BLOOD LANCET. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Gainor Medical. The FDA issued a Cleared decision on January 29, 1987 after a review of 748 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K850100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
633d slower than avg
Panel avg: 115d · This submission: 748d
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 K850100.
TENDERFOOT(R), MODIFICATION
K911997 · International Technidyne Corp. · Jul 1991
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
K902430 · Heraeus Kulzer, Inc. · Aug 1990
TENDERFOOT
K883968 · International Technidyne Corp. · Dec 1988
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