510(k) · Cleared
ClearedMICROLET®NEXT Lancet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascensia Diabetes Care U.S., Inc. · QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Cleared on Aug 15, 2024 as substantially equivalent to K221507 (SteriLance Medical (Suzhou), Inc., 2022) after a 55-day review. Its family tree reaches back 4 generations to 1982.
- Decided
- Aug 15, 2024
- Review
- 55 days
- Class
- Class II
- Product code
- QRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K822209 (1982). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK822209 AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic · 1982
- 3 generations backK101145 Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300…Medipurpose Pte., Ltd. · 2010
- 2 generations backK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
- 1 generation backK221507 Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022
- This deviceK241810 MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K822209 | Autolancet | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982 | — |
| −3 | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | Medipurpose Pte., Ltd. | 2010 | — |
| −2 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| −1 | K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2022 | — |
| 0 (this device) | K241810 | MICROLET®NEXT Lancet | Ascensia Diabetes Care U.S., Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2012 | 1 | 0 |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K221507 | Disposable Blood LancetSummary page 4…878.4850 Product Code(s) QRK I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221507 STERILANCE DISPOSABLE BLOOD LANCET QRK Device Description Summary 21 CFR 807.92(a)(4) The disposable MICROLET®NEXT Lancet is use… | 2022 |
| † | K221970 | Lancing device | 2022 |
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.
What does this lineage say?
- The line of descent spans 42 years and passes through 5 companies; a new generation was cleared every 9.1 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K221507.
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. 2024, 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?
The disposable MICROLET®NEXT Lancet is used for capillary blood collection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241810: MICROLET®NEXT Lancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241810
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026