# K231124: Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford, Ltd.
- Decided: Jun 27, 2023 after 68 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: 3 generations back to K822209 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221126: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets, Owen Mumford, Ltd. (2022) Summary page 7.

## Indications for use
The Unistik® 3 single-use safety lancets are hand-held, disposable devices intended to be used to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.

Source page: https://510kreport.com/device/K231124
Methodology: https://510kreport.com/methodology