510(k) K222084
K222084 is an FDA 510(k) premarket notification submitted by Asahi Polyslider Co., Ltd. for the device "OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie". The FDA issued a decision of Substantially Equivalent on Nov 2, 2022. The device falls under product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850. Asahi Polyslider Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 2, 2022
- Date Received
- Jul 15, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
- 510(k)
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.