Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Verisafe Safety Retractable Insulin Syringes

K-Number: K250192 · 2025-12-10

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2025-12-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Verisafe Safety Retractable Insulin Syringes is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-10 under approval number K250192. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Verisafe Safety Retractable Insulin Syringes?

Verisafe Safety Retractable Insulin Syringes is a medical device that received FDA 510(k) clearance on 2025-12-10. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K250192.

When was Verisafe Safety Retractable Insulin Syringes approved by the FDA?

Verisafe Safety Retractable Insulin Syringes received FDA 510(k) clearance on 2025-12-10, under approval number K250192.

What company makes Verisafe Safety Retractable Insulin Syringes?

Verisafe Safety Retractable Insulin Syringes is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Verisafe Safety Retractable Insulin Syringes?

The FDA product code for Verisafe Safety Retractable Insulin Syringes is FMF.

Related Clinical Trials

NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07602036 Type 2 Diabetes and Pregnancy a Single-arm Interventional Study NOT_YET_RECRUITING NCT05785832 A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes COMPLETED

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K202682Promisemed Triple Safety Pen Needle

View all 35 devices →

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

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.

↑