Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
FDA 510(k) K243533 · Hlb Co., Ltd. Healthcare
Submission
- Device name
- Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
- Applicant
- Hlb Co., Ltd. Healthcare
Sejong-Si, KR - Received
- November 15, 2024
- Decision date
- January 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4850
- Specialty
- General, Plastic Surgery
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…
Other 510(k)s with product code FMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262526 | Safety lancet (XL)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 09/13/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/01/2026SE |
| K260191 | Safety lancet (XXXVII)FMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 03/31/2026SE |
| K253605 | Safety Heel LancetFMK · Traditional | Ningbo Medsun Medical Co., Ltd. | 02/20/2026SE |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)FMK · Special | Tianjin Huahong Technology Co., Ltd. | 02/12/2026SE |
| K251694 | safety lancetFMK · Special | Tianjin Huahong Technology Co., Ltd. | 06/26/2025SE |
| K244036 | Heel Incision Safety Lancet (SteriHeel 2)FMK · Traditional | SteriLance Medical (Suzhou), Inc. | 02/26/2025SE |
| K242680 | LetsGetChecked ImpressFMK · Traditional | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 01/13/2025SESU |
| K242664 | gentleheel® Adult Incision DeviceFMK · Traditional | Gri-Alleset, Inc. | 11/05/2024SE |
| K242627 | Safety LancetFMK · Traditional | Ningbo Medsun Medical Co., Ltd. | 10/30/2024SE |
Questions and answers
When was Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus cleared by the FDA?
Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533) received a 510(k) decision of Substantially Equivalent on January 13, 2025, 59 days after the submission was received.
What is the product code of K243533?
The FDA product code is FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.