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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 a medical device manufactured by Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under approval 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. It is manufactured by Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K253706.

When was Lancing device (HH-XV-T) approved by the FDA?

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

What company makes Lancing device (HH-XV-T)?

Lancing device (HH-XV-T) is manufactured by Tianjin Huahong Technology Co., Ltd..

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 Devices by Tianjin Huahong Technology Co., Ltd.

K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-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) K221176Insulin Pen Needle K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III) 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)

View all 12 devices →

Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health

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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