# K221126: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford, Ltd.
- 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: 2 generations back to K822209 (1982). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101145: Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250, Medipurpose Pte., Ltd. (2010) Summary page 4.

## Most influential descendants
- K231124: Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) (2023), 0 descendants of its own

## Indications for use
The 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/K221126
Methodology: https://510kreport.com/methodology