# K222539: Facet Blood Lancets

- Pathway: 510(k) (Traditional)
- Applicant: Facet Technologies, LLC
- Decided: Nov 18, 2022 after 88 days
- Product code: QRL (Multiple Use Blood Lancet For Single Patient Use Only)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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 30G and 33G Lancet: named in the summary without a submission number

## Indications for use
The Facet Lancet is a sterile, disposable single use device used with a compatible proprietary lancet base (lancing device) to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing. 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/K222539
Methodology: https://510kreport.com/methodology