510(k) K242622
K242622 is an FDA 510(k) premarket notification submitted by Ningbo Caremed Medical Products Co., Ltd. for the device "Sterile Lancets for Single Use". The FDA issued a decision of Substantially Equivalent on October 28, 2024. The device falls under product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850. Ningbo Caremed Medical Products Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2024
- Date Received
- September 3, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.