# K243533: Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

- Pathway: 510(k) (Traditional)
- Applicant: Hlb Co., Ltd. Healthcare
- Decided: Jan 13, 2025 after 59 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: 4 generations back to K822209 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221368: Promisemed Blood Lancet,  VeriFine Safety Lancet, VeriFine Mini-Safety Lancet, Promisemed Hangzhou Meditech Co., Ltd. (2022) Summary page 5.

## Indications for use
It is intended for capillary blood sampling.

Source page: https://510kreport.com/device/K243533
Methodology: https://510kreport.com/methodology