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FDA 510(k)

DropSafe Safety Pen Needles

K-Number: K211716 · 2022-01-07

ApplicantHtl Strefa SA
Decision Date2022-01-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DropSafe Safety Pen Needles is the device name listed in this FDA 510(k) record. The listed applicant is Htl Strefa SA. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211716. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DropSafe Safety Pen Needles?

DropSafe Safety Pen Needles is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Htl Strefa SA. The 510(k) number is K211716.

When did DropSafe Safety Pen Needles receive FDA 510(k) clearance?

DropSafe Safety Pen Needles received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211716.

Who is the listed applicant for DropSafe Safety Pen Needles?

The FDA 510(k) record lists Htl Strefa SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DropSafe Safety Pen Needles?

The FDA product code for DropSafe Safety Pen Needles is FMI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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

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