# K221546: OneTouch Delica Plus Lancing System

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Polyslider Co., Ltd.
- Decided: Aug 23, 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
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 OneTouch@ Delica@ Plus lancets are sterile, single use devices that have been designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples from the fingertips. The OneTouch Delica Plus lancets are compatible with the single patient use OneTouch@ Delica@ Plus lancing device.

Source page: https://510kreport.com/device/K221546
Methodology: https://510kreport.com/methodology