# K220917: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

- Pathway: 510(k) (Traditional)
- Applicant: Gri-Alleset, Inc.
- Decided: May 18, 2022 after 49 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 K883968 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172712: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler, Gri Medical & Electronic Technology Co., Ltd. (2017) Summary page 4.
- K883968: Tenderfoot, International Technidyne Corp. (1988) Summary page 4.
- K911997: Tenderfoot (R), Modification, International Technidyne Corp. (1991) Summary page 4.

## Most influential descendants
- K242664: gentleheel® Adult Incision Device (2024), 0 descendants of its own

## Indications for use
The intended use of this device is for newborn babies and toddlers of any ethnicity where a blood sample is desired, and a self-retracting safety feature is desired to protect the clinician performing the blood sampling.

Source page: https://510kreport.com/device/K220917
Methodology: https://510kreport.com/methodology