510(k) · Cleared
ClearedONE DROP Lancing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stat Medical Devices · QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Cleared on Feb 15, 2023 as substantially equivalent to K214022 (Roche Diabetes Care, Inc., 2022) after a 57-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Feb 15, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- QRK
- 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 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 |
|---|---|---|---|
| * | K214022 | Accu-Chek Softclix Blood Lancing SystemSummary page 5…y blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting. Legally Marketed Predicate Device Predicate #: K214022 Predicate Trade Name: Accu-Chek Softclix Blood Lancing System Product Code: QRL, QRK Similarities and Differences between Candida… | 2022 |
| † | K221383 | MedtFine Blood Lancet | 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 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 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. 2023, 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 One Drop Lancing Device is for use with One Drop branded Lancets to collect capillary blood for testing purposes from the fingertip. The One Drop Lancing Device is for single patient use in a home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223815: ONE DROP 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/K223815
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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