FMK — Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Class II
Classification Details
- Product Code
- FMK
- Device Class
- Class II
- Regulation Number
- 878.4850
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253605 | ningbo medsun medical co | Safety Heel Lancet | February 20, 2026 |
| K252490 | tianjin huahong technology co | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | February 12, 2026 |
| K251694 | tianjin huahong technology co | safety lancet | June 26, 2025 |
| K244036 | sterilance medical (suzhou) | Heel Incision Safety Lancet (SteriHeel 2) | February 26, 2025 |
| K243533 | hlb co., ltd. healthcare | Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | January 13, 2025 |
| K242680 | privapath diagnostics ltd (dba letsgetchecked) | LetsGetChecked Impress | January 13, 2025 |
| K242664 | gri-alleset | gentleheel® Adult Incision Device | November 5, 2024 |
| K242627 | ningbo medsun medical co | Safety Lancet | October 30, 2024 |
| K242316 | ningbo medsun medical co | Safety Lancet | August 28, 2024 |
| K241848 | ningbo caremed medical products co | MedtFine Safety Lancet | August 20, 2024 |
| K241750 | medifun corporation | Medifun Safety Lancet ( MSL1 series) | August 15, 2024 |
| K241627 | tianjin huahong technology co | Safety Lancet (XXXV) | June 20, 2024 |
| K240806 | tianjin huahong technology co | Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) | May 21, 2024 |
| K234081 | reddrop dx | RedDrop ONE (One) | March 21, 2024 |
| K223826 | drawbridge health | NanoDrop Lancet | February 22, 2024 |
| K233796 | sterilance medical (suzhou) | Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disp | January 16, 2024 |
| K232488 | roche diabetes care | Accu-Chek Safe-T-Pro Plus Lancing Device | November 13, 2023 |
| K232509 | roche diabetes care | Accu-Chek Safe-T-Pro Uno Lancing Device | November 13, 2023 |
| K231124 | owen mumford | Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), | June 27, 2023 |
| K223201 | yourbio health | TAP Lancet | April 19, 2023 |