Cleared Special

K221368 - Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet

K221368 is an FDA 510(k) clearance for Promisemed Blood Lancet, manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Special 510(k) pathway after a 28-day FDA review.

K221368 · Promisemed Hangzhou Meditech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
28d
Days
Class 2
Risk

K221368 is an FDA 510(k) clearance for the Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on June 9, 2022 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221368

510(k) Number K221368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2022
Decision Date June 09, 2022
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FMK Device Classification - Class 2, Special Controls

Product Code FMK Single Use Only Blood Lancet With 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, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use.
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

Vee Care (Asia) Limited
Wei Shan Hsu

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 - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 109
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K221368.
Unistik® 3, sterile single-use safety lancets
K221126 · Owen Mumford, Ltd. · Aug 2022
Tasso+
K221131 · Tasso, Inc. · Aug 2022
DropSafe Acti-Lance Safety Lancets
K220643 · Htl-Strefa S.A · Jul 2022
Promisemed Heel Blood Lancet
K221371 · Promisemed Hangzhou Meditech Co., Ltd. · Jun 2022
Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
K220370 · Tianjin Huahong Technology Co., Ltd. · May 2022
Accu-Chek Safe-T-Pro Plus Lancing Device
K220849 · Roche Diabetes Care, Inc. · May 2022
K221368 · Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Download PDF FDA Summary Promisemed Hangzhou M…