# K234081: RedDrop ONE (One)

- Pathway: 510(k) (Traditional)
- Applicant: Reddrop DX
- Decided: Mar 21, 2024 after 90 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: 6 generations back to K822209 (1982). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223201: TAP Lancet, Yourbio Health, Inc. (2023) Summary page 5.

## Indications for use
The RedDrop ONE 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/K234081
Methodology: https://510kreport.com/methodology