# K024170: L1 System

- Pathway: 510(k) (Traditional)
- Applicant: Pelikan Technologies, Inc.
- Decided: Apr 14, 2003 after 117 days
- Product code: FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature)
- Device class: 2
- Regulation: 21 CFR 878.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931258 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931258: Softtouch II Lancet Device, Boehringer Mannheim Corp. (1994) Summary page 1.

## Indications for use
The L1 System is an automatic blood lancet device used to obtain a capillary blood sample.

Source page: https://510kreport.com/device/K024170
Methodology: https://510kreport.com/methodology