Cleared Traditional

K220387 - Disposable Blood Lancets

K220387 is an FDA 510(k) clearance for Disposable Blood Lancets, manufactured by Suzhou Kyuan Medical Apparatus Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code QRL cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K220387 · Suzhou Kyuan Medical Apparatus Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
188d
Days
Class 2
Risk

K220387 is an FDA 510(k) clearance for the Disposable Blood Lancets. Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Suzhou Kyuan Medical Apparatus Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 17, 2022 after a review of 188 days - an extended review 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: 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 Suzhou Kyuan Medical Apparatus Co., Ltd. devices

FDA 510(k) Submission Details - K220387

510(k) Number K220387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2022
Decision Date August 17, 2022
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QRL Device Classification - Class 2, Special Controls

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 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 K220387.
RightLance Blood Lancing System
K222034 · Beijing Ruicheng Medical Supplies Co., Ltd. · Sep 2022
Lancing device
K221970 · SteriLance Medical (Suzhou), Inc. · Aug 2022
OneTouch Delica Plus Lancing System
K221546 · Asahi Polyslider 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
Accu-Chek FastClix Blood Lancing System
K220608 · Roche Diabetes Care, Inc. · Apr 2022