FDA 510(k) Applications for Medical Device Product Code "QRL"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K221175 | Arkray, Inc. | Multi-Lancet Device 2, ReliOn Premier Lancing Device | 10/17/2022 |
| K221546 | Asahi Polyslider Co., Ltd. | OneTouch Delica Plus Lancing System | 08/23/2022 |
| K220633 | Ascensia Diabetes Care US Inc | MICROLET NEXT lancing device, MICROLET Lancet | 06/03/2022 |
| K250813 | Ascensia Diabetes Care US Inc | MICROLET«NEXT 2 Lancing Device | 05/14/2025 |
| K222034 | Beijing Ruicheng Medical Supplies Co., Ltd. | RightLance Blood Lancing System | 09/07/2022 |
| K221062 | Bionime Corporation | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | 09/26/2022 |
| K222539 | Facet Technologies LLC | Facet Blood Lancets | 11/18/2022 |
| K223099 | Facet Technologies LLC | Facet Manatee Reusable Lancing Base | 11/28/2022 |
| K232912 | Facet Technologies, LLC | Facet Aurora Reusable Lancet Base | 01/25/2024 |
| K221419 | GOSTAR Co., Ltd. | TD-5010 Lancing Device and TD-5084 Sterile Lancets | 01/20/2023 |
| K222656 | i-SENS, Inc. | LDE4 Lancing Device | 11/23/2022 |
| K231797 | Medifun Corporation | Medifun Lancing Device, Model No. LD-E1 | 11/22/2023 |
| K221613 | Owen Mumford Ltd | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | 10/03/2022 |
| K223643 | Promisemed Hangzhou Meditech Co., Ltd. | Verifine« Ease Lancing Device, Verifine« Lancing Device | 02/21/2023 |
| K220608 | Roche Diabetes Care, Inc | Accu-Chek FastClix Blood Lancing System | 04/29/2022 |
| K214022 | Roche Diabetes Care, Inc. | Accu-Chek Softclix Blood Lancing System | 02/17/2022 |
| K222472 | Shandong Lianfa Medical Plastic Products Co. Ltd. | Lancing System, Sterile Lancet for Single Use, Lancing Device | 11/30/2022 |
| K221970 | SteriLance Medical(Suzhou) Inc. | Lancing device | 08/30/2022 |
| K220387 | Suzhou Kyuan Medical Apparatus Co., Ltd. | Disposable Blood Lancets | 08/17/2022 |
| K220475 | Tianjin Huahong Technology Co., Ltd. | 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) | 07/06/2022 |
| K243306 | Tianjin Huahong Technology Co., Ltd. | 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-X | 11/15/2024 |
| K222246 | Tianjin Rilifine Medical Device Co., Ltd. | Disposable Sterile Lancet | 11/21/2022 |
| K221072 | Trividia Health | TRUEdraw Lancing Device, Mini Lancing Device | 10/18/2022 |
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