510(k) · Cleared
ClearedTRUEdraw Lancing Device, Mini Lancing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trividia Health · QRL Multiple Use Blood Lancet For Single Patient Use Only
Cleared on Oct 18, 2022 as substantially equivalent to K214022 (Roche Diabetes Care, Inc., 2022) after a 189-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Oct 18, 2022
- Review
- 189 days
- Class
- Class II
- Product code
- QRL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810075 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K214022 | Accu-Chek Softclix Blood Lancing SystemSummary page 4…878.4850(c) Product Code QRL Legally Marketed Predicate Device 21 CFR 807.92(a)(3) Predicate # K214022 Predicate Trade Name Accu-Chek Softclix Blood Lancing Device Product Code QRL… | 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 41 years and passes through 3 companies; a new generation was cleared every 41.0 years on median.
- None of the 2 ancestors has a recall.
- 11 other devices also cite its predicate K214022.
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?
The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.
The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.
The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.
The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221072: TRUEdraw Lancing Device, Mini Lancing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221072
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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