Safety Lancet
FDA 510(k) K222801 · Sarstedt AG & CO KG
Submission
- Device name
- Safety Lancet
- Applicant
- Sarstedt AG & CO KG
Nuembrecht, DE - Received
- September 16, 2022
- Decision date
- January 25, 2023
- 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…
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|---|---|---|---|
| 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 |
| K243533 | Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusFMK · Traditional | Hlb Co., Ltd. Healthcare | 01/13/2025SE |
| K242680 | LetsGetChecked ImpressFMK · Traditional | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 01/13/2025SESU |
| K242664 | gentleheel® Adult Incision DeviceFMK · Traditional | Gri-Alleset, Inc. | 11/05/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K051019 | Safety NeedleJKA · Traditional | 07/25/2005SE |
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| K031359 | S-Monovette Edta K2-GELPJE · Traditional | 09/12/2003SE |
| K024237 | Urine Monovette Boric AcidJSM · Traditional | 04/14/2003SE |
| K003382 | Sarstedt Needle ProtectorFMI · Traditional | 03/30/2001SE |
| K913622 | HemoplusKHE · Traditional | 01/31/1992SE |
Questions and answers
When was Safety Lancet cleared by the FDA?
Safety Lancet (K222801) received a 510(k) decision of Substantially Equivalent on January 25, 2023, 131 days after the submission was received.
What is the product code of K222801?
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.