DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
K220643 is the FDA 510(k) clearance record for DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets, a class II device, cleared for Htl-Strefa S.A on under FDA product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature). FDA's definition for product code FMK reads: "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...". FDA records list 8 510(k) clearances for Htl-Strefa S.A, from to . As of , FDA records show no recalls naming K220643.
Clearance record
- Decision date
- Received
- (126 days to decision)
- Product code
- FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Regulation
- 21 CFR 878.4850
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Htl-Strefa S.A Adamowek 7, Ozorkow, PL
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code FMK
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 2 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
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