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FDA 510(k)

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)

K-Number: K222376 · 2022-10-03

Decision Date2022-10-03
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. It received FDA 510(k) clearance on 2022-10-03 under 510(k) number K222376. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. The 510(k) number is K222376.

When did Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) receive FDA 510(k) clearance?

Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) received FDA 510(k) clearance on 2022-10-03, under 510(k) number K222376.

Who is the listed applicant for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

The FDA 510(k) record lists Shandong Lianfa Medical Plastic Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)?

The FDA product code for Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is FMK.

Other records listing Shandong Lianfa Medical Plastic Products 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.

Related Devices (Code: FMK)

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.

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.