LDE4 Lancing Device
FDA 510(k) K222656 · I-Sens, Inc.
510(k) numberK222656
Submission
- Device name
- LDE4 Lancing Device
- Applicant
- I-Sens, Inc.
Seoul, KR - Received
- September 2, 2022
- Decision date
- November 23, 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 |
|---|---|---|
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring SystemNBW · Special | 08/10/2023SE |
| K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose…NBW · Special | 10/05/2021SE |
| K201551 | KetoSens BT Blood B-Ketone Monitoring SystemJIN · Special | 09/09/2020SE |
| K192859 | CareSens S Clear BT Blood Glucose Monitoring SystemNBW · Special | 01/24/2020SE |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring SystemNBW · Special | 01/17/2020SE |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring SystemNBW · Special | 12/13/2019SE |
| K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…NBW · Special | 11/01/2018SE |
| K180866 | CareSens S Fit Blood Glucose Monitoring SystemNBW · Traditional | 08/31/2018SE |
| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional | 04/13/2018SE |
| K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemNBW · Special | 12/13/2017SE |
Questions and answers
When was LDE4 Lancing Device cleared by the FDA?
LDE4 Lancing Device (K222656) received a 510(k) decision of Substantially Equivalent on November 23, 2022, 82 days after the submission was received.
What is the product code of K222656?
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.