FDA 510(k)

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

K-Number: K161950 · 2017-05-11

ApplicantPromisemed Hangzhou Meditech Co., Ltd.

Decision Date2017-05-11

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle 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 2017-05-11 under 510(k) number K161950. 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 Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle?

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K161950.

When did Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle receive FDA 510(k) clearance?

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle received FDA 510(k) clearance on 2017-05-11, under 510(k) number K161950.

Who is the listed applicant for Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle?

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 Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle?

The FDA product code for Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle 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.

NCT05515939Evaluating the InPen in Pediatric Type 1 DiabetesACTIVE_NOT_RECRUITING NCT06406439DIA:CONN P8(Smart Insulin Pen) Study in Diabetes PatientsCOMPLETED

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

K261196Promisemed VeriEcto Automatic Biopsy Needles K261045Verifine Safety Lancets K254273Verisafe Safety Sterile Needles (SSN)K250192Verisafe Safety Retractable Insulin Syringes K250961Blood collection tube holders K251138Promisemed Safety Huber Needles

View all 35 devices →

Related Devices (Code: FMI)

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.K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd.K254273Verisafe Safety Sterile Needles (SSN)Promisemed Hangzhou Meditech 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.