Facet Blood Lancets
FDA 510(k) K222539 · Facet Technologies, LLC
510(k) numberK222539
Submission
- Device name
- Facet Blood Lancets
- Applicant
- Facet Technologies, LLC
Atlanta, GA, US - Received
- August 22, 2022
- Decision date
- November 18, 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 |
|---|---|---|
| K232912 | Facet Aurora Reusable Lancet BaseQRL · Traditional | 01/25/2024SE |
| K223370 | NeatNick Heel Safety LancetFMK · Traditional | 02/13/2023SE |
| K223099 | Facet Manatee Reusable Lancing BaseQRL · Traditional | 11/28/2022SE |
| K221433 | Facet 28G Universal LancetQRK · Traditional | 07/15/2022SE |
| K141749 | Carefine Pen Needle Family Including Quintapoint and SuperpointFMI · Special | 07/29/2014SE |
| K140568 | Carefine Pen Needle with Quintapoint and SuperpointFMI · Special | 05/13/2014SE |
| K133100 | Carefine Pen NeedleFMI · Traditional | 01/23/2014SE |
Questions and answers
When was Facet Blood Lancets cleared by the FDA?
Facet Blood Lancets (K222539) received a 510(k) decision of Substantially Equivalent on November 18, 2022, 88 days after the submission was received.
What is the product code of K222539?
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.