# K101417: Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200

- Pathway: 510(k) (Abbreviated)
- Applicant: Medipurpose Pte., Ltd.
- Decided: Oct 19, 2010 after 152 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
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K082209: Devilbiss DV5M Smartlink System, Sunrise Medical (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K130132: Babylance Heel Incision Device (2013), 9 descendants of its own
- K193009: Promisemed Heel Blood Lancet (2019), 7 descendants of its own
- K210745: Heel Incision Safety Lancet (2021), 5 descendants of its own
- K220372: Heel Stick Safety Lancet (HHZ-II, HHZ-III) (2022), 1 descendant of its own
- K253605: Safety Heel Lancet (2026), 0 descendants of its own

## Indications for use
The babyLanceTM is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLanCeTm has a sharps prevention feature to protect the user from a sharps injury.

Source page: https://510kreport.com/device/K101417
Methodology: https://510kreport.com/methodology