# K221062: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Sep 26, 2022 after 168 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
Longest line of descent: 4 generations back to K002134 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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 6.
- K153670: Genteel Lancing Device, Genteel, LLC (2016) Summary page 6.

## Most influential descendants
- K231797: Medifun Lancing Device, Model No. LD-E1 (2023), 0 descendants of its own

## Indications for use
RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device. GE Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device. iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.

Source page: https://510kreport.com/device/K221062
Methodology: https://510kreport.com/methodology