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FDA 510(k)

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)

K-Number: K214075 · 2022-04-12

ApplicantAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Decision Date2022-04-12
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K214075. 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 Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)?

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K214075.

When did Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) receive FDA 510(k) clearance?

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) received FDA 510(k) clearance on 2022-04-12, under 510(k) number K214075.

Who is the listed applicant for Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)?

The FDA product code for Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) is FMI.

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Other records listing Anhui Hongyu Wuzhou Medical Manufacturer 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.

K234024HWJECT Auto-disable syringeK230061Insulin SyringeK230043Insulin Pen NeedleK223323Blood Collection Needle (with/without Needle Holder)K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleK222141Safety Blood Collection Needle (Without Needle Holder)

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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.

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.

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