# K223201: TAP Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Yourbio Health, Inc.
- Decided: Apr 19, 2023 after 187 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: 5 generations back to K822209 (1982). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221131: Tasso+, Tasso, Inc. (2022) Summary page 5.

## Most influential descendants
- K242680: LetsGetChecked Impress (2025), 0 descendants of its own
- K234081: RedDrop ONE (One) (2024), 0 descendants of its own

## Indications for use
The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

Source page: https://510kreport.com/device/K223201
Methodology: https://510kreport.com/methodology