# K221433: Facet 28G Universal Lancet

- Pathway: 510(k) (Traditional)
- Applicant: Facet Technologies, LLC
- Decided: Jul 15, 2022 after 59 days
- Product code: QRK (Single Use Only Blood Lancet Without 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Facet 28G Universal Lancet: named in the summary without a submission number

## Most influential descendants
- K223480: Medipoint Blood Lancets (2023), 0 descendants of its own

## Indications for use
The Facet 28G Universal Lancet is a sterile, disposable single use device used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.

Source page: https://510kreport.com/device/K221433
Methodology: https://510kreport.com/methodology