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FDA 510(k)

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

K-Number: K192666 · 2019-12-02

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2019-12-02
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2019-12-02 under approval number K192666. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet?

Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet is a medical device that received FDA 510(k) clearance on 2019-12-02. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K192666.

When was Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet approved by the FDA?

Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet received FDA 510(k) clearance on 2019-12-02, under approval number K192666.

What company makes Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet?

Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet?

The FDA product code for Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet is FMK.

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Related PubMed Literature

PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 32192636 Food and Drug Administration's Perspective on Medical Devices Intended for Weight Loss: A Guide for the Interventional Radiologist. Techniques in vascular and interventional radiology (2020) PMID: 28114192 FDA Benchmark Medical Device Flow Models for CFD Validation. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2017)

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle K211890Promisemed Sharps container

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Related Devices (Code: FMK)

K153670Genteel Lancing DeviceGenteel, LLC K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsBecton, Dickinson and Company K222408Disposable Safety LancetBeijing Ruicheng Medical Supplies Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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