Cleared Traditional

Unistik® 3, sterile single-use safety lancets (K221126) - FDA 510(k) Clearance

Also marketed or referenced as:
Unistik® 3 Value, sterile single-use safety lancets Abbott SF sterile single-use safety lancets

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

K221126 · Owen Mumford, Ltd. · General & Plastic Surgery device
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Aug 2022
Decision
116d
Days
Class 2
Risk

K221126 is an FDA 510(k) clearance for the Unistik® 3, sterile single-use safety lancets. 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 August 12, 2022 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Owen Mumford, Ltd. devices

Submission Details

510(k) Number K221126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2022
Decision Date August 12, 2022
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
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 63
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K221126.
Lancet
K221839 · Hebei Xinle Sci&Tech Co., Ltd. · Sep 2022
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
K222111 · Owen Mumford, Ltd. · Sep 2022
SafetiHeel, MediHeel, Novaplus
K221604 · Nsp Tech Pte, Ltd. · Aug 2022
Tasso+
K221131 · Tasso, Inc. · Aug 2022
DropSafe Acti-Lance Safety Lancets
K220643 · Htl-Strefa S.A · Jul 2022
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K221368 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2022