# K222084: OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Polyslider Co., Ltd.
- Decided: Nov 2, 2022 after 110 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: 2 generations back to K822209 (1982). 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)
- K101145: Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250, Medipurpose Pte., Ltd. (2010) Summary page 5.

## Indications for use
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip. HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury. Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury. Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury. Capiject® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury. Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury. Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.

Source page: https://510kreport.com/device/K222084
Methodology: https://510kreport.com/methodology