Product code QRL
- Device name
- Multiple Use Blood Lancet For Single Patient Use Only
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4850
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253706 | Lancing device (HH-XV-T) | Tianjin Huahong Technology Co., Ltd. | 2025-12-09 |
| K250813 | MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. | 2025-05-14 |
| 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, 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... | Tianjin Huahong Technology Co., Ltd. | 2024-11-15 |
| K232912 | Facet Aurora Reusable Lancet Base | Facet Technologies, LLC | 2024-01-25 |
| K231797 | Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation | 2023-11-22 |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-21 |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile Lancets | Gostar Co., Ltd. | 2023-01-20 |
| K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-11-30 |
| K223099 | Facet Manatee Reusable Lancing Base | Facet Technologies, LLC | 2022-11-28 |
| K222656 | LDE4 Lancing Device | I-Sens, Inc. | 2022-11-23 |
| K222246 | Disposable Sterile Lancet | Tianjin Rilifine Medical Device Co., Ltd. | 2022-11-21 |
| K222539 | Facet Blood Lancets | Facet Technologies, LLC | 2022-11-18 |
| K221072 | TRUEdraw Lancing Device, Mini Lancing Device | Trividia Health | 2022-10-18 |
| K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | Arkray, Inc. | 2022-10-17 |
| K221613 | Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets | Owen Mumford, Ltd. | 2022-10-03 |
| K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | Bionime Corporation | 2022-09-26 |
| K222034 | RightLance Blood Lancing System | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-09-07 |
| K221970 | Lancing device | SteriLance Medical (Suzhou), Inc. | 2022-08-30 |
| K221546 | OneTouch Delica Plus Lancing System | Asahi Polyslider Co., Ltd. | 2022-08-23 |
| K220387 | Disposable Blood Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-08-17 |
| 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-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | Tianjin Huahong Technology Co., Ltd. | 2022-07-06 |
| K220633 | MICROLET NEXT lancing device, MICROLET Lancet | Ascensia Diabetes Care U.S., Inc. | 2022-06-03 |
| K220608 | Accu-Chek FastClix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-04-29 |
| K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022-02-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16945630142007 | STERiLANCE | Sterilance Medical (Suzhou) Inc. | 2026-03-09 |
| 16945630136167 | TRANSTEK | Sterilance Medical (Suzhou) Inc. | 2025-04-22 |
| 16945630132534 | STERiLANCE Soft Disposable Blood Lancet | Sterilance Medical (Suzhou) Inc. | 2024-10-23 |
| 16945630132527 | STERiLANCE LDE4 Lancing Device | Sterilance Medical (Suzhou) Inc. | 2024-10-23 |
| 20612479265695 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2024-01-30 |
| 20612479265664 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2024-01-30 |
| 16945630123488 | SteriLance OneStep | Sterilance Medical (Suzhou) Inc. | 2024-01-15 |
| 00015482880163 | TechLITE® Lancets, 26g | ARKRAY USA, INC. | 2023-09-27 |
| 00010939958686 | TRUEdraw | TRIVIDIA HEALTH, INC. | 2023-08-01 |
| 10810011730318 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730325 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730332 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730356 | metene | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730363 | metene | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730301 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730295 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730288 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730271 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730264 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 10810011730257 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2023-04-28 |
| 15060988910007 | JJ CARE | Jack Jack LLC | 2023-03-15 |
| 10612479265445 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2023-03-03 |
| 00041220916474 | H.E.B. inControl | H. E. BUTT GROCERY COMPANY | 2023-01-11 |
| 10810011730370 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2022-08-12 |
| 10810011730349 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2022-08-12 |
| 10810011730233 | Care Touch | Tianjin Huahong Technology Co., Ltd. | 2022-07-08 |
| 10810011730226 | HUAHONG | Tianjin Huahong Technology Co., Ltd. | 2022-05-30 |
| 00010939709448 | TRUEdraw | TRIVIDIA HEALTH, INC. | 2020-12-14 |
| 00011822741088 | TRUEdraw | TRIVIDIA HEALTH, INC. | 2020-12-14 |
| 00021292142018 | TRUEdraw | TRIVIDIA HEALTH, INC. | 2020-12-14 |