# K242664: gentleheel® Adult Incision Device

- Pathway: 510(k) (Traditional)
- Applicant: Gri-Alleset, Inc.
- Decided: Nov 5, 2024 after 62 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: 3 generations back to K883968 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220917: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler, Gri-Alleset, Inc. (2022) Summary page 5.
- K172712: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler, Gri Medical & Electronic Technology Co., Ltd. (2017) Summary page 5.

## Indications for use
The gentleheel® Adult Incision Device is a single-use lancing device intended to obtain microliter capillary blood samples. The gentleheel® Adult Incision Device has a sharps prevention feature to protect the user from a needlestick injury.

Source page: https://510kreport.com/device/K242664
Methodology: https://510kreport.com/methodology