# K223900: babyLance Safety Heelstick (BLM, BLN, BLP)

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Innovations, LLC
- Decided: Feb 24, 2023 after 58 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: 2 generations back to K101417 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130132: Babylance Heel Incision Device, Medipurpose Pte., Ltd. (2013) Summary page 4.

## Indications for use
The babyLance safety heelstick is a single-use incision device used to obtain a blood sample from the heel of a neonate or infant. babyLance has a sharps prevention feature to protect the user from a needlestick injury.

Source page: https://510kreport.com/device/K223900
Methodology: https://510kreport.com/methodology