FDA 510(k)

ULTICARE DISPOSABLE PEN NEEDLES

K-Number: K100812 · 2010-06-03

Decision Date2010-06-03

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ULTICARE DISPOSABLE PEN NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed, Inc.. It received FDA 510(k) clearance on 2010-06-03 under 510(k) number K100812. 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 ULTICARE DISPOSABLE PEN NEEDLES?

ULTICARE DISPOSABLE PEN NEEDLES is a medical device that received FDA 510(k) clearance on 2010-06-03. The listed applicant is Ultimed, Inc.. The 510(k) number is K100812.

When did ULTICARE DISPOSABLE PEN NEEDLES receive FDA 510(k) clearance?

ULTICARE DISPOSABLE PEN NEEDLES received FDA 510(k) clearance on 2010-06-03, under 510(k) number K100812.

Who is the listed applicant for ULTICARE DISPOSABLE PEN NEEDLES?

The FDA 510(k) record lists Ultimed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTICARE DISPOSABLE PEN NEEDLES?

The FDA product code for ULTICARE DISPOSABLE 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ultimed, Inc. as applicant

K080600ULTIMED ULTICARE SAFETY SYRINGE K081449ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER K062702ULTICARE DISPOSABLE SYRINGES AND NEEDLES K050464ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 K033794ULTICARE DISPOSABLE SYRINGE 3 ML/CC K021983ULTI GUARD HOME INSULIN SYRINGE CONTAINER

View all 8 devices →

Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed 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

View on FDA Database →

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