Cleared Traditional

K222303 - Unistik® Pro (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222303 · Owen Mumford, Ltd. · General & Plastic Surgery device
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Oct 2022
Decision
85d
Days
Class 2
Risk

K222303 is an FDA 510(k) clearance for the Unistik® Pro. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Owen Mumford, Ltd. (Woodstock, GB). The FDA issued a Cleared decision on October 25, 2022 after a review of 85 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 Owen Mumford, Ltd. devices

Submission Details

510(k) Number K222303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2022
Decision Date October 25, 2022
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 114d · This submission: 85d
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 Consultant

Owen Mumford USA, Inc.
Patty Cronan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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