Cleared Traditional

K942620 - FEATHER-TOUCH SINGLE-STICK DEVICE

K942620 is the FDA 510(k) clearance for FEATHER-TOUCH SINGLE-STICK DEVICE by Ulster Scientific, Inc.. It is a Class 2 General & Plastic Surgery device (product code FMK) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K942620 · Ulster Scientific, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
20d
Days
Class 2
Risk

K942620 is an FDA 510(k) clearance for the FEATHER-TOUCH SINGLE-STICK DEVICE. 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. (New Paltz, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 20 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

Submission Details

510(k) Number K942620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1994
Decision Date June 22, 1994
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
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 66
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K942620.
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BABISTICK
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