Cleared Traditional

K232330 - Lancing System

K232330 is an FDA 510(k) clearance for Lancing System, manufactured by Ningbo Medsun Medical Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code QRK cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K232330 · Ningbo Medsun Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
154d
Days
Class 2
Risk

K232330 is an FDA 510(k) clearance for the Lancing System. Classified as Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (product code QRK), Class II - Special Controls.

Submitted by Ningbo Medsun Medical Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on January 4, 2024 after a review of 154 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 Ningbo Medsun Medical Co., Ltd. devices

FDA 510(k) Submission Details - K232330

510(k) Number K232330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2023
Decision Date January 04, 2024
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QRK Device Classification - Class 2, Special Controls

Product Code QRK Single Use Only Blood Lancet Without 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, Nonreusable 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 - QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

All 16
Devices cleared under the same product code (QRK) and FDA review panel - the closest regulatory comparables to K232330.
Disposable Blood Lancet (Soft Pro)
K244031 · SteriLance Medical (Suzhou), Inc. · Feb 2025
Sterile Lancets for Single Use
K242622 · Ningbo Caremed Medical Products Co., Ltd. · Oct 2024
MICROLET®NEXT Lancet
K241810 · Ascensia Diabetes Care U.S., Inc. · Aug 2024
SG Lanset I, SG Lancets, Soft Lancets
K230712 · Sewon Medical Co. · Dec 2023
STAT Medical Device Lancing System
K230310 · Stat Medical Devices · Sep 2023
SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
K230759 · Bosungmeditech Co., Ltd. · Jun 2023