510(k) · Cleared
ClearedSafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bosungmeditech Co., Ltd. · QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Cleared on Jun 13, 2023 after an 85-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Jun 13, 2023
- Review
- 85 days
- Class
- Class II
- Product code
- QRK
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRK device
- #1 K221507 Disposable Blood Lancetscore 16.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K042422 | FDA’s K042422 is D3 Chroma Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QRK devicesQRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QRK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRK
55in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QRK
No recall names QRK since 2007.
Adverse event reports per year · QRK
9in 2025
MAUDE reports naming product code QRK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 100 | 0 | 2 |
| 2023 | 7 | 89 | 0 | 12 |
| 2024 | 3 | 55 | 0 | 10 |
| 2025 | 2 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230759: SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230759
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026