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FDA 510(k)

Facet Blood Lancets

K-Number: K222539 · 2022-11-18

ApplicantFacet Technologies, LLC
Decision Date2022-11-18
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Facet Blood Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Facet Technologies, LLC. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222539. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Facet Blood Lancets?

Facet Blood Lancets is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Facet Technologies, LLC. The 510(k) number is K222539.

When did Facet Blood Lancets receive FDA 510(k) clearance?

Facet Blood Lancets received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222539.

Who is the listed applicant for Facet Blood Lancets?

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

What is the FDA product code for Facet Blood Lancets?

The FDA product code for Facet Blood Lancets is QRL.

Other records listing Facet Technologies, LLC 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.

K232912Facet Aurora Reusable Lancet BaseK223370NeatNick Heel Safety LancetK223099Facet Manatee Reusable Lancing BaseK221433Facet 28G Universal Lancet

Related Devices (Code: QRL)

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.

K262211LancetTianjin Huahong Technology Co., Ltd.K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.K232912Facet Aurora Reusable Lancet BaseFacet Technologies, LLC

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.

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