Decision Date2026-07-22
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K262211. 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 Lancet?
Lancet is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K262211.
When did Lancet receive FDA 510(k) clearance?
Lancet received FDA 510(k) clearance on 2026-07-22, under 510(k) number K262211.
Who is the listed applicant for Lancet?
The FDA 510(k) record lists Tianjin Huahong Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lancet?
The FDA product code for Lancet is QRL.
Other records listing Tianjin Huahong 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.
K260191Safety lancet (XXXVII)K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)K253706Lancing device (HH-XV-T)K251694safety lancetK243306Lancet (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)K241627Safety Lancet (XXXV) View all 13 devices →
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.
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, LLCK231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation
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.