510(k) · Cleared
ClearedDisposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SteriLance Medical (Suzhou), Inc. · QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Cleared on Feb 26, 2025 as substantially equivalent to K221507 (SteriLance Medical (Suzhou), Inc., 2022) after a 58-day review. Its family tree reaches back 4 generations to 1982. 1 later device descends from it.
- Decided
- Feb 26, 2025
- Review
- 58 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK244031 Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet…SteriLance Medical (Suzhou), Inc. · 2025
- Descendant · cites it directly · 0 of its ownK262631 Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc. · 2026 · cites it directly0descendants
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) | K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure)… | SteriLance Medical (Suzhou), Inc. | 2025 | — |
| +1 | K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 5…se blood lancet for single patient use only) Submission type Traditional 510(K) 3. Predicate Device SteriLance Medical (Suzhou) Inc., Disposable Blood Lancet, under K221507. 4. Device Description Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood s… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | 2026 | 0 |
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 43 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K262631 (SteriLance Medical (Suzhou), Inc., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2025, 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?
Disposable Blood Lancet is used for capillary blood sampling.
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/K244031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244031: Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244031
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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