Cleared Traditional

K242622 - Sterile Lancets for Single Use (FDA 510(k) Clearance)

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

K242622 · Ningbo Caremed Medical Products Co., Ltd. · General & Plastic Surgery device
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Oct 2024
Decision
55d
Days
Class 2
Risk

K242622 is an FDA 510(k) clearance for the Sterile Lancets for Single Use. Classified as Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (product code QRK), Class II - Special Controls.

Submitted by Ningbo Caremed Medical Products Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on October 28, 2024 after a review of 55 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 Ningbo Caremed Medical Products Co., Ltd. devices

Submission Details

510(k) Number K242622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date October 28, 2024
Days to Decision 55 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
59d faster than avg
Panel avg: 114d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Landlink Healthcare Technology (Shanghai) Co., Ltd.
Kyra Kang

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 - QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

All 14
Devices cleared under the same product code (QRK) and FDA review panel - the closest regulatory comparables to K242622.
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SG Lanset I, SG Lancets, Soft Lancets
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STAT Medical Device Lancing System
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