Atlas FDA

Lancet

FDA 510(k) clearance K262211 · decided 2026-07-22

Clearance details

K-number
K262211
Device name
Lancet
Applicant
Tianjin Huahong Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2026-06-30
Decision date
2026-07-22
Days to decision
22 days
Clearance type
Special
Product code
QRL
Device class
2
Regulation number
878.4850
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Tianjin, CN
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) (K260122)SteriLance Medical (Suzhou), Inc.2026-07-06
Lancing device (HH-XV-T) (K253706)Tianjin Huahong Technology Co., Ltd.2025-12-09
MICROLET®NEXT 2 Lancing Device (K250813)Ascensia Diabetes Care U.S., Inc.2025-05-14
Lancet (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) (K243306)Tianjin Huahong Technology Co., Ltd.2024-11-15
Facet Aurora Reusable Lancet Base (K232912)Facet Technologies, LLC2024-01-25
Medifun Lancing Device, Model No. LD-E1 (K231797)Medifun Corporation2023-11-22
Verifine® Ease Lancing Device, Verifine® Lancing Device (K223643)Promisemed Hangzhou Meditech Co., Ltd.2023-02-21
TD-5010 Lancing Device and TD-5084 Sterile Lancets (K221419)Gostar Co., Ltd.2023-01-20
Lancing System, Sterile Lancet for Single Use, Lancing Device (K222472)Shandong Lianfa Medical Plastic Products Co. , Ltd.2022-11-30
Facet Manatee Reusable Lancing Base (K223099)Facet Technologies, LLC2022-11-28
LDE4 Lancing Device (K222656)I-Sens, Inc.2022-11-23
Disposable Sterile Lancet (K222246)Tianjin Rilifine Medical Device Co., Ltd.2022-11-21

Recalls involving this device

No recalls on record reference this clearance.