Multi-Lancet Device 2, ReliOn Premier Lancing Device
FDA 510(k) K221175 · Arkray, Inc.
510(k) numberK221175
Submission
- Device name
- Multi-Lancet Device 2, ReliOn Premier Lancing Device
- Applicant
- Arkray, Inc.
Kyoto, JP - Received
- April 25, 2022
- Decision date
- October 17, 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 |
|---|---|---|
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis SystemLKM · Traditional | 05/03/2024SE |
| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | 04/13/2023SE |
| K200788 | Assure Titanium Blood Glucose Monitoring SystemPZI · Dual Track | 05/23/2022SE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional | 10/07/2016SE |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | 02/01/2013SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | 12/23/2009SE |
| K053401 | Spotchem II Chemistry Basic 1 and Chemistry Basic 2 TestsCIC · Traditional | 03/24/2006SE |
| K051648 | Spotchem II Inoganic Phosphorus, CPK and Uric Acid TestsCGS · Traditional | 01/31/2006SE |
| K051432 | Spotchem II Total Bilirubin, Total Protein and Albumin TestsCIG · Traditional | 06/17/2005SE |
| K050790 | Spotchem II LDH TestCFH · Traditional | 06/06/2005SE |
Questions and answers
When was Multi-Lancet Device 2, ReliOn Premier Lancing Device cleared by the FDA?
Multi-Lancet Device 2, ReliOn Premier Lancing Device (K221175) received a 510(k) decision of Substantially Equivalent on October 17, 2022, 175 days after the submission was received.
What is the product code of K221175?
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.