Cleared Traditional

ONE DROP Lancing Device (K223815) - FDA 510(k) Clearance

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

K223815 · Stat Medical Devices · General & Plastic Surgery device
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Feb 2023
Decision
57d
Days
Class 2
Risk

K223815 is an FDA 510(k) clearance for the ONE DROP Lancing Device. Classified as Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (product code QRK), Class II - Special Controls.

Submitted by Stat Medical Devices (North Miami Beach, US). The FDA issued a Cleared decision on February 15, 2023 after a review of 57 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 Stat Medical Devices devices

Submission Details

510(k) Number K223815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2022
Decision Date February 15, 2023
Days to Decision 57 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
58d faster than avg
Panel avg: 115d · This submission: 57d
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

FDA Compliance Group
Kevin Walls

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 K223815.
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
EasyTouch Lancing Device
K222617 · Stat Medical Devices · Mar 2023
Disposable Blood Lancets
K223314 · Huaian Hening Medical Instruments Co., Ltd. · Jan 2023
Medipoint Blood Lancets
K223480 · Medipoint Holdings, LLC · Jan 2023
MedtFine Blood Lancet
K221383 · Shanghai Carelife International Trading Co. , Ltd. · Sep 2022