# K221419: TD-5010 Lancing Device and TD-5084 Sterile Lancets

- Pathway: 510(k) (Traditional)
- Applicant: Gostar Co., Ltd.
- Decided: Jan 20, 2023 after 249 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: 2 generations back to K810075 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214022: Accu-Chek Softclix Blood Lancing System, Roche Diabetes Care, Inc. (2022) Summary page 4.

## Indications for use
The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of. For use only on a single patient in a home setting. Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Source page: https://510kreport.com/device/K221419
Methodology: https://510kreport.com/methodology