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FDA 510(k)

Auto Disable Syringe

K-Number: K210464 · 2021-08-24

ApplicantAnhui Tiankang Medical Technology Co., Ltd.
Decision Date2021-08-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Auto Disable Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) number K210464. 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 Auto Disable Syringe?

Auto Disable Syringe is a medical device that received FDA 510(k) clearance on 2021-08-24. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K210464.

When did Auto Disable Syringe receive FDA 510(k) clearance?

Auto Disable Syringe received FDA 510(k) clearance on 2021-08-24, under 510(k) number K210464.

Who is the listed applicant for Auto Disable Syringe?

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

What is the FDA product code for Auto Disable Syringe?

The FDA product code for Auto Disable Syringe is FMF.

Other records listing Anhui Tiankang Medical Technology 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.

K222773Feeding TubeK222772Oral/Enteral Syringe with ENFit connectorK230756TK Pre-Filled Normal Saline Flush SyringeK222385Bifurcated NeedleK220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needleK212368Surgical Face Mask

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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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