510(k) · Cleared
ClearedDisposable Blood Lancet
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 Aug 31, 2022 as substantially equivalent to K192666 (Promisemed Hangzhou Meditech Co., Ltd., 2019) after a 100-day review. Its family tree reaches back 3 generations to 1982. 5 later devices descend from it.
- Decided
- Aug 31, 2022
- Review
- 100 days
- Class
- Class II
- Product code
- QRK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K822209 (1982). 5 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK822209 AutolancetBd Becton Dickinson Vacutainer Systems Preanalytic · 1982
- 2 generations backK101145 Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300…Medipurpose Pte., Ltd. · 2010
- 1 generation backK192666 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine…Promisemed Hangzhou Meditech Co., Ltd. · 2019
- This deviceK221507 Disposable Blood LancetSteriLance Medical (Suzhou), Inc. · 2022
- Descendant · cites it directly · 1 of its ownK244031 Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet…SteriLance Medical (Suzhou), Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK262631 Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261634 Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250016 droplet® personal lancetsHtl-Strefa S.A · 2025
- Descendant · cites it directly · 0 of its ownK241810 MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…SteriLance Medical (Suzhou), Inc. · 2025 · cites it directly1descendant
- K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc. · 2026 · 2 generations on0descendants
- K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc. · 2026 · cites it directly0descendants
- K250016droplet® personal lancetsHtl-Strefa S.A · 2025 · cites it directly0descendants
- K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K822209 | Autolancet | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982 | — |
| −2 | K101145 | Surgilance Safety Lancets, Models SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 | Medipurpose Pte., Ltd. | 2010 | — |
| −1 | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019 | — |
| 0 (this device) | K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2022 | — |
| +1 | K244031 | Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure)… | SteriLance Medical (Suzhou), Inc. | 2025 | — |
| +2 | K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. | 2026 | — |
| +1 | K261634 | Disposable Blood Lancet (Soft) | SteriLance Medical (Suzhou), Inc. | 2026 | — |
| +1 | K250016 | droplet® personal lancets | Htl-Strefa S.A | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 K262631 Disposable blood lancet (Soft Pro, Softsure…score 13.1 · 5 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 |
|---|---|---|---|
| * | K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetSummary page 4…21 CFR 878.4800 Regulation class I Regulation name Manual Surgical Instrument for General Use 510(k) Number K192666 Product Code FMK Manufacturer Promisemed Hangzhou Meditech Co., Ltd.… | 2019 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 40 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K244031 (SteriLance Medical (Suzhou), Inc., 2025) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K192666.
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. 2022, 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 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/K221507 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221507: Disposable Blood Lancet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221507
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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