510(k) K221613
K221613 is an FDA 510(k) premarket notification submitted by Owen Mumford, Ltd. for the device "Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets". The FDA issued a decision of Substantially Equivalent on October 3, 2022. The device falls under product code QRL (Multiple Use Blood Lancet For Single Patient Use Only), a Class II device regulated under 21 CFR 878.4850. Owen Mumford, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2022
- Date Received
- June 3, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Multiple Use Blood Lancet For Single Patient Use Only
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.