# K911997: Tenderfoot (R), Modification

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Jul 17, 1991 after 86 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.
4 later devices descend from it; 3 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K172712: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (2017), 2 descendants of its own
- K220917: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler (2022), 1 descendant of its own
- K242664: gentleheel® Adult Incision Device (2024), 0 descendants of its own
- K223352: Tenderfoot (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K911997
Methodology: https://510kreport.com/methodology