# K223826: NanoDrop Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Drawbridge Health, Inc.
- Decided: Feb 22, 2024 after 428 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.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223208: Safety Lancet, Suzhou Zhenwu Medical Co., Ltd. (2023). Cleared while this submission was under review Summary page 4.

## Indications for use
The NanoDrop Lancet is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.

Source page: https://510kreport.com/device/K223826
Methodology: https://510kreport.com/methodology