Cleared Traditional

OneTouch Delica Plus Lancing System (K221546) - FDA 510(k) Clearance

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

K221546 · Asahi Polyslider Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
88d
Days
Class 2
Risk

K221546 is an FDA 510(k) clearance for the OneTouch Delica Plus Lancing System. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Asahi Polyslider Co., Ltd. (Maniwa, JP). The FDA issued a Cleared decision on August 23, 2022 after a review of 88 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 Asahi Polyslider Co., Ltd. devices

Submission Details

510(k) Number K221546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2022
Decision Date August 23, 2022
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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

Emergo by UL
Stuart R. Goldman

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 K221546.
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
Disposable Blood Lancets
K220387 · Suzhou Kyuan Medical Apparatus Co., Ltd. · Aug 2022
Lancet (I, II, III, V, VI)
K220475 · Tianjin Huahong Technology Co., Ltd. · Jul 2022
MICROLET NEXT lancing device, MICROLET Lancet
K220633 · Ascensia Diabetes Care U.S., Inc. · Jun 2022