Cleared Traditional

K861243 - NEONATAL UNILET

K861243 is an FDA 510(k) clearance for NEONATAL UNILET, manufactured by Ulster Scientific, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K861243 · Ulster Scientific, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
27d
Days
Class 2
Risk

K861243 is an FDA 510(k) clearance for the NEONATAL UNILET. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on April 29, 1986 after a review of 27 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 Ulster Scientific, Inc. devices

FDA 510(k) Submission Details - K861243

510(k) Number K861243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1986
Decision Date April 29, 1986
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 77
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K861243.
THE AUTOLET LITE
K894474 · Ulster Scientific, Inc. · Aug 1989
TENDERFOOT
K883968 · International Technidyne Corp. · Dec 1988
DIALET LANCING DEVICE
K861265 · Home Diagnostics, Inc. · Apr 1986
SUEL BLOOD LANCET
K861151 · Exel Intl. · Apr 1986
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
K855203 · Miles Laboratories, Inc. · Feb 1986
CHURCHHILL LANCET
K854760 · Churchill Corp. · Jan 1986