Cleared Traditional

K861265 - DIALET LANCING DEVICE

K861265 is an FDA 510(k) clearance for DIALET LANCING DEVICE, manufactured by Home Diagnostics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K861265 · Home Diagnostics, Inc. · General & Plastic Surgery device
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Apr 1986
Decision
26d
Days
Class 2
Risk

K861265 is an FDA 510(k) clearance for the DIALET LANCING DEVICE. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Home Diagnostics, Inc. (Eatontown, US). The FDA issued a Cleared decision on April 30, 1986 after a review of 26 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 Home Diagnostics, Inc. devices

FDA 510(k) Submission Details - K861265

510(k) Number K861265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1986
Decision Date April 30, 1986
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
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 81
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K861265.
GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
K902430 · Heraeus Kulzer, Inc. · Aug 1990
THE AUTOLET LITE
K894474 · Ulster Scientific, Inc. · Aug 1989
TENDERFOOT
K883968 · International Technidyne Corp. · Dec 1988
NEONATAL UNILET
K861243 · Ulster Scientific, Inc. · Apr 1986
SUEL BLOOD LANCET
K861151 · Exel Intl. · Apr 1986
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
K855203 · Miles Laboratories, Inc. · Feb 1986