# K153670: Genteel Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: Genteel, LLC
- Decided: May 12, 2016 after 143 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 K002134 (2000). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113332: ON Call Chosen Lancing Device, ACON Laboratories, Inc. (2012) Summary page 4.
- (no number) Autolet® Impression Lancing Device: named in the summary without a submission number

## Most influential descendants
- K221062: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (2022), 1 descendant of its own
- K231797: Medifun Lancing Device, Model No. LD-E1 (2023), 0 descendants of its own
- K223643: Verifine® Ease Lancing Device, Verifine® Lancing Device (2023), 0 descendants of its own

## Indications for use
The Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood. The Genteel lancing device is for Single Patient Use Only.

Source page: https://510kreport.com/device/K153670
Methodology: https://510kreport.com/methodology