Panels › General, Plastic Surgery › Product code QRL · Class 2
Multiple Use Blood Lancet For Single Patient Use Only
Regulation 878.4850
4510(k)s in 12 months (27 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in QRL
| Company | 510(k)s | Recalls |
|---|---|---|
| Tianjin Huahong Technology Co., Ltd. | 5 | 0 |
| Facet Technologies, LLC | 3 | 0 |
| Ascensia Diabetes Care U.S., Inc. | 2 | 0 |
| Roche Diabetes Care, Inc. | 2 | 0 |
| SteriLance Medical (Suzhou), Inc. | 2 | 0 |
| Arkray, Inc. | 1 | 0 |
| Asahi Polyslider Co., Ltd. | 1 | 0 |
| Beijing Ruicheng Medical Supplies Co., Ltd. | 1 | 0 |
| Bionime Corporation | 1 | 0 |
| Gostar Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2026 | K262135 | Lancing device Tianjin Huahong Technology Co., Ltd., CN | QRL |
| Jul 22, 2026 | K262211 | Lancet Tianjin Huahong Technology Co., Ltd., CN | QRL |
| Jul 6, 2026 | K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) SteriLance Medical (Suzhou), Inc., CN | QRL |
| Dec 9, 2025 | K253706 | Lancing device (HH-XV-T) Tianjin Huahong Technology Co., Ltd., CN | QRL |
| May 14, 2025 | K250813 | MICROLET®NEXT 2 Lancing Device Ascensia Diabetes Care U.S., Inc. | QRL |
| Nov 15, 2024 | K243306 | 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, Tianjin Huahong Technology Co., Ltd., CN | QRL |
| Jan 25, 2024 | K232912 | Facet Aurora Reusable Lancet Base Facet Technologies, LLC | QRL |
| Nov 22, 2023 | K231797 | Medifun Lancing Device, Model No. LD-E1 Medifun Corporation, TW | QRL |
| Feb 21, 2023 | K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device Promisemed Hangzhou Meditech Co., Ltd., CN | QRL |
| Jan 20, 2023 | K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets Gostar Co., Ltd., TW | QRL |
| Nov 30, 2022 | K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device Shandong Lianfa Medical Plastic Products Co. , Ltd., CN | QRL |
| Nov 28, 2022 | K223099 | Facet Manatee Reusable Lancing Base Facet Technologies, LLC | QRL |
| Nov 23, 2022 | K222656 | LDE4 Lancing Device I-Sens, Inc., KR | QRL |
| Nov 21, 2022 | K222246 | Disposable Sterile Lancet Tianjin Rilifine Medical Device Co., Ltd., CN | QRL |
| Nov 18, 2022 | K222539 | Facet Blood Lancets Facet Technologies, LLC | QRL |
| Oct 18, 2022 | K221072 | TRUEdraw Lancing Device, Mini Lancing Device Trividia Health | QRL |
| Oct 17, 2022 | K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device Arkray, Inc., JP | QRL |
| Oct 3, 2022 | K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets Owen Mumford, Ltd., GB | QRL |
| Sep 26, 2022 | K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device Bionime Corporation, TW | QRL |
| Sep 7, 2022 | K222034 | RightLance Blood Lancing System Beijing Ruicheng Medical Supplies Co., Ltd., CN | QRL |
| Aug 30, 2022 | K221970 | Lancing device SteriLance Medical (Suzhou), Inc., CN | QRL |
| Aug 23, 2022 | K221546 | OneTouch Delica Plus Lancing System Asahi Polyslider Co., Ltd., JP | QRL |
| Aug 17, 2022 | K220387 | Disposable Blood Lancets Suzhou Kyuan Medical Apparatus Co., Ltd., CN | QRL |
| Jul 6, 2022 | K220475 | 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- Tianjin Huahong Technology Co., Ltd., CN | QRL |
| Jun 3, 2022 | K220633 | MICROLET NEXT lancing device, MICROLET Lancet Ascensia Diabetes Care U.S., Inc. | QRL |
| Apr 29, 2022 | K220608 | Accu-Chek FastClix Blood Lancing System Roche Diabetes Care, Inc. | QRL |
| Feb 17, 2022 | K214022 | Accu-Chek Softclix Blood Lancing System Roche Diabetes Care, Inc. | QRL |
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