# K223352: Tenderfoot

- Pathway: 510(k) (Special)
- Applicant: Accriva Diagnostics, Inc.
- Decided: Mar 2, 2023 after 120 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: 1 generation back to K883968 (1988). 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)
- K883968: Tenderfoot, International Technidyne Corp. (1988) Summary page 4.
- K911997: Tenderfoot (R), Modification, International Technidyne Corp. (1991) Summary page 4.

## Indications for use
Tenderfoot is a sterile incision device intended to initiate capillary blood flow via a heel stick with infants and toddlers. For medical device use. For healthcare professional use, prescription only.

Source page: https://510kreport.com/device/K223352
Methodology: https://510kreport.com/methodology