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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 the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2025-12-10 under 510(k) 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. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K250192.

When did Verisafe Safety Retractable Insulin Syringes receive FDA 510(k) clearance?

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

Who is the listed applicant for Verisafe Safety Retractable Insulin Syringes?

The FDA 510(k) record lists Promisemed Hangzhou Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Promisemed Hangzhou Meditech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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