Cleared Traditional

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets (K221613) - FDA 510(k) Clearance

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

K221613 · Owen Mumford, Ltd. · General & Plastic Surgery device
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Oct 2022
Decision
122d
Days
Class 2
Risk

K221613 is an FDA 510(k) clearance for the Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Owen Mumford, Ltd. (Woodstock, GB). The FDA issued a Cleared decision on October 3, 2022 after a review of 122 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 K221613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2022
Decision Date October 03, 2022
Days to Decision 122 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
7d slower than avg
Panel avg: 115d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRL Multiple Use Blood Lancet For Single Patient Use Only
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition A Multiple Use Capable Blood Lancet Intended For Use On A Single Patient That Is Comprised Of A Single Use Blade Attached To A Solid, Reusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes.
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.

Regulatory Peers - QRL Multiple Use Blood Lancet For Single Patient Use Only

All 23
Devices cleared under the same product code (QRL) and FDA review panel - the closest regulatory comparables to K221613.
Facet Blood Lancets
K222539 · Facet Technologies, LLC · Nov 2022
TRUEdraw Lancing Device, Mini Lancing Device
K221072 · Trividia Health · Oct 2022
Multi-Lancet Device 2, ReliOn Premier Lancing Device
K221175 · Arkray, Inc. · Oct 2022
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
K221062 · Bionime Corporation · Sep 2022
RightLance Blood Lancing System
K222034 · Beijing Ruicheng Medical Supplies Co., Ltd. · Sep 2022
Lancing device
K221970 · SteriLance Medical (Suzhou), Inc. · Aug 2022