MICROLET NEXT lancing device, MICROLET Lancet
FDA 510(k) K220633 · Ascensia Diabetes Care U.S., Inc.
510(k) numberK220633
Submission
- Device name
- MICROLET NEXT lancing device, MICROLET Lancet
- Applicant
- Ascensia Diabetes Care U.S., Inc.
Parsippany, NJ, US - Received
- March 4, 2022
- Decision date
- June 3, 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 |
|---|---|---|
| K250813 | MICROLET®NEXT 2 Lancing DeviceQRL · Traditional | 05/14/2025SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | 08/27/2024SE |
| K241810 | MICROLET®NEXT LancetQRK · Traditional | 08/15/2024SE |
| K223293 | CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW · Special | 11/18/2022SE |
| K162336 | Contour Next EZ Blood Glucose Monitoring SystemNBW · Special | 01/12/2017SE |
| K160430 | Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…NBW · Special | 06/24/2016SE |
Questions and answers
When was MICROLET NEXT lancing device, MICROLET Lancet cleared by the FDA?
MICROLET NEXT lancing device, MICROLET Lancet (K220633) received a 510(k) decision of Substantially Equivalent on June 3, 2022, 91 days after the submission was received.
What is the product code of K220633?
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.