Atlas FDA

QRL

26 FDA 510(k) clearances · Product code

91 daysmedian time to decision
188 days90th percentile
26clearances measured

FDA profile

Official device name
Multiple Use Blood Lancet For Single Patient Use Only
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4850
Medical specialty
General, Plastic Surgery
FDA definition
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Adverse events (MAUDE)
2025: 134 · 2026: 93
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Lancet (K262211)Tianjin Huahong Technology Co., Ltd.2026-07-22
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
Facet Blood Lancets (K222539)Facet Technologies, LLC2022-11-18
TRUEdraw Lancing Device, Mini Lancing Device (K221072)Trividia Health2022-10-18
Multi-Lancet Device 2, ReliOn Premier Lancing Device (K221175)Arkray, Inc.2022-10-17
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets (K221613)Owen Mumford, Ltd.2022-10-03
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (K221062)Bionime Corporation2022-09-26
RightLance Blood Lancing System (K222034)Beijing Ruicheng Medical Supplies Co., Ltd.2022-09-07
Lancing device (K221970)SteriLance Medical (Suzhou), Inc.2022-08-30
OneTouch Delica Plus Lancing System (K221546)Asahi Polyslider Co., Ltd.2022-08-23
Disposable Blood Lancets (K220387)Suzhou Kyuan Medical Apparatus Co., Ltd.2022-08-17
Lancet (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) (K220475)Tianjin Huahong Technology Co., Ltd.2022-07-06
MICROLET NEXT lancing device, MICROLET Lancet (K220633)Ascensia Diabetes Care U.S., Inc.2022-06-03
Accu-Chek FastClix Blood Lancing System (K220608)Roche Diabetes Care, Inc.2022-04-29
Accu-Chek Softclix Blood Lancing System (K214022)Roche Diabetes Care, Inc.2022-02-17

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Every clearance here is in the API, with alerts when new ones post.