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FDA 510(k)

Lancing device (HH-XV-T)

K-Number: K253706 · 2025-12-09

ApplicantTianjin Huahong Technology Co., Ltd.
Decision Date2025-12-09
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lancing device (HH-XV-T) 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 2025-12-09 under 510(k) number K253706. 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 Lancing device (HH-XV-T)?

Lancing device (HH-XV-T) is a medical device that received FDA 510(k) clearance on 2025-12-09. The listed applicant is Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K253706.

When did Lancing device (HH-XV-T) receive FDA 510(k) clearance?

Lancing device (HH-XV-T) received FDA 510(k) clearance on 2025-12-09, under 510(k) number K253706.

Who is the listed applicant for Lancing device (HH-XV-T)?

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 Lancing device (HH-XV-T)?

The FDA product code for Lancing device (HH-XV-T) 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.

K260845Huahong Sharps Container (HHR-I, HHR-II)K262211LancetK260191Safety lancet (XXXVII)K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)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)

View all 14 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.

K262211LancetTianjin Huahong Technology Co., Ltd.K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.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.

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