Cleared Traditional

K220475 - Lancet (I, II, III, V, VI) (FDA 510(k) Clearance)

Also includes:
Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)

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

K220475 · Tianjin Huahong Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
138d
Days
Class 2
Risk

K220475 is an FDA 510(k) clearance for the Lancet (I, II, III, V, VI). Classified as Multiple Use Blood Lancet For Single Patient Use Only (product code QRL), Class II - Special Controls.

Submitted by Tianjin Huahong Technology Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on July 6, 2022 after a review of 138 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 Tianjin Huahong Technology Co., Ltd. devices

Submission Details

510(k) Number K220475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2022
Decision Date July 06, 2022
Days to Decision 138 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
24d slower than avg
Panel avg: 114d · This submission: 138d
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

Landlink Healthcare Technology (Shanghai) Co., Ltd.
Stuart Situ

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 K220475.
Lancing device (HH-XV-T)
K253706 · Tianjin Huahong Technology Co., Ltd. · Dec 2025
MICROLET®NEXT 2 Lancing Device
K250813 · Ascensia Diabetes Care U.S., Inc. · May 2025
Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)
K243306 · Tianjin Huahong Technology Co., Ltd. · Nov 2024
Facet Aurora Reusable Lancet Base
K232912 · Facet Technologies, LLC · Jan 2024
Medifun Lancing Device, Model No. LD-E1
K231797 · Medifun Corporation · Nov 2023
Verifine® Ease Lancing Device, Verifine® Lancing Device
K223643 · Promisemed Hangzhou Meditech Co., Ltd. · Feb 2023