RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
FDA 510(k) K221062 · Bionime Corporation
510(k) numberK221062
Submission
- Device name
- RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
- Applicant
- Bionime Corporation
Taichung City, TW - Received
- April 11, 2022
- Decision date
- September 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QRL – Multiple Use Blood Lancet For Single Patient Use Only
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4850
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code QRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262135 | Lancing deviceQRL · Traditional | Tianjin Huahong Technology Co., Ltd. | 08/18/2026SE |
| K262211 | LancetQRL · Special | Tianjin Huahong Technology Co., Ltd. | 07/22/2026SE |
| K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)QRL · Traditional | SteriLance Medical (Suzhou), Inc. | 07/06/2026SE |
| K253706 | Lancing device (HH-XV-T)QRL · Special | Tianjin Huahong Technology Co., Ltd. | 12/09/2025SE |
| K250813 | MICROLET®NEXT 2 Lancing DeviceQRL · Traditional | Ascensia Diabetes Care U.S., Inc. | 05/14/2025SE |
| K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…QRL · Special | Tianjin Huahong Technology Co., Ltd. | 11/15/2024SE |
| K232912 | Facet Aurora Reusable Lancet BaseQRL · Traditional | Facet Technologies, LLC | 01/25/2024SE |
| K231797 | Medifun Lancing Device, Model No. LD-E1QRL · Traditional | Medifun Corporation | 11/22/2023SE |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing DeviceQRL · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 02/21/2023SE |
| K221419 | TD-5010 Lancing Device and TD-5084 Sterile LancetsQRL · Traditional | Gostar Co., Ltd. | 01/20/2023SE |
More from Gostar Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | 11/04/2024SE |
| K231192 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | 01/19/2024SE |
| K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring…NBW · Traditional | 06/02/2019SE |
| K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System…NBW · Traditional | 08/17/2018SE |
| K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System…NBW · Traditional | 06/19/2018SE |
| K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest…NBW · Traditional | 07/06/2017SE |
| K161790 | iGlucose Blood Glucose Monitoring SystemNBW · Traditional | 05/02/2017SE |
| K140210 | Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720NBW · Traditional | 08/22/2014SE |
| K133003 | Rightest Control SolutionJJX · Traditional | 10/24/2013SE |
| K123008 | Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System…NBW · Special | 01/25/2013SE |
Questions and answers
When was RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device cleared by the FDA?
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (K221062) received a 510(k) decision of Substantially Equivalent on September 26, 2022, 168 days after the submission was received.
What is the product code of K221062?
The FDA product code is QRL – Multiple Use Blood Lancet For Single Patient Use Only, a Class II (moderate risk) device regulated under 21 CFR 878.4850.