# K230759: SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Bosungmeditech Co., Ltd.
- Decided: Jun 13, 2023 after 85 days
- Product code: QRK (Single Use Only Blood Lancet Without 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K042422: D3 Chroma, Sybron Dental Specialties, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
SafeLan® is sterile, single use device that has been designed for single patient use by lay users in a home. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples. SafeLan®-Pro: Use with SafeLan® for capillary blood sampling and the SafeLan®-Pro as the multiple use execution device which the SafeLan® lancet attaches.

Source page: https://510kreport.com/device/K230759
Methodology: https://510kreport.com/methodology