# K221131: Tasso+

- Pathway: 510(k) (Traditional)
- Applicant: Tasso, Inc.
- Decided: Aug 12, 2022 after 116 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: 4 generations back to K822209 (1982). 6 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K220370: Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI), Tianjin Huahong Technology Co., Ltd. (2022). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K223201: TAP Lancet (2023), 2 descendants of its own
- K242680: LetsGetChecked Impress (2025), 0 descendants of its own
- K234081: RedDrop ONE (One) (2024), 0 descendants of its own

## Indications for use
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.

Source page: https://510kreport.com/device/K221131
Methodology: https://510kreport.com/methodology