510(k) · Cleared
ClearedLancing device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SteriLance Medical (Suzhou), Inc. · QRL Multiple Use Blood Lancet For Single Patient Use Only
Cleared on Aug 30, 2022 as substantially equivalent to K113332 (ACON Laboratories, Inc., 2012) after a 56-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 30, 2022
- Review
- 56 days
- Class
- Class II
- Product code
- QRL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002134 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- 2 generations backK090057 ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009
- 1 generation backK113332 ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012
- This deviceK221970 Lancing deviceSteriLance Medical (Suzhou), Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260122 Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250813 MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| −2 | K090057 | ON-Call Plus Blood Glucose Monitoring System | Acon Laboratories Co. | 2009 | — |
| −1 | K113332 | ON Call Chosen Lancing Device | ACON Laboratories, Inc. | 2012 | — |
| 0 (this device) | K221970 | Lancing device | SteriLance Medical (Suzhou), Inc. | 2022 | — |
| +1 | K260122 | Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep) | SteriLance Medical (Suzhou), Inc. | 2026 | — |
| +1 | K250813 | MICROLET®NEXT 2 Lancing Device | Ascensia Diabetes Care U.S., Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 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 QRL? 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 QRL device
- #1 K214022 Accu-Chek Softclix Blood Lancing Systemscore 38.9 · 1 generation · 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 |
|---|---|---|---|
| * | K113332 | ON Call Chosen Lancing DeviceSummary page 5…nt use Classification only / QRL Submission type Traditional 510(K) 3. Predicate Device ACON Laboratories, Inc., On call® Lancing device under K113332. 4. Device Description Lancing device is used with disposable blood lancet to obtain capillary blood samples. It has multiple pe… | 2012 |
What descends from it? (2)
2 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 22 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260122 (SteriLance Medical (Suzhou), Inc., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K113332.
How does its category compare?
All QRL devicesQRL Multiple Use Blood Lancet For Single Patient Use Only: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QRL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRL
155in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QRL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QRL
133in 2025
MAUDE reports naming product code QRL, 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 | 17 | 91 | 0 | 1 |
| 2023 | 3 | 155 | 0 | 3 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 2 | — | 1 | 133 |
| 2026 | 3 | 54 | 0 | — |
What is it indicated for?
Lancing device is used with disposable blood lancet to obtain capillary blood samples.
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/K221970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221970: Lancing device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221970
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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