510(k) · Cleared
ClearedAccu-Chek Safe-T-Pro Uno Lancing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diabetes Care, Inc. · FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Cleared on Nov 13, 2023 as substantially equivalent to K220364 (Roche Diabetes Care, Inc., 2022) after an 87-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Nov 13, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- FMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K822209 (1982). No later device cites it as a predicate yet.
- 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 backK220364 Accu-Chek Safe-T-Pro Uno Lancing DeviceRoche Diabetes Care, Inc. · 2022
- This deviceK232509 Accu-Chek Safe-T-Pro Uno Lancing DeviceRoche Diabetes Care, Inc. · 2023
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 | K220364 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | 2022 | — |
| 0 (this device) | K232509 | Accu-Chek Safe-T-Pro Uno Lancing Device | Roche Diabetes Care, Inc. | 2023 | — |
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 FMK? 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 FMK device
- #1 K220370 Safety Lancet (XIII, XVII, XXI, XXII, XXIII…score 25.0 · 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 |
|---|---|---|---|
| * | K220364 | Accu-Chek Safe-T-Pro Uno Lancing DeviceSummary page 4…integral sharps injury prevention feature Regulation Number: 878.4850, Class II Product Code: FMK Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)] Predicate #1: K220364 Predicate Trade Name: Accu-Chek Safe-T-Pro Uno Lancing Device Product Code: FMK Legally Marketed Reference Devices [21 CFR 807.9… | 2022 |
| † | K222090 | Safety Lancet | 2022 |
| † | K221433 | Facet 28G Universal 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 41 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FMK devicesFMK Single Use Only Blood Lancet With 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 · FMK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMK
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMK
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FMK
47in 2025
MAUDE reports naming product code FMK, 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 | — | 4 | 1,206 |
| 2008 | 0 | — | 2 | 1,100 |
| 2009 | 0 | — | 1 | 882 |
| 2010 | 2 | — | 0 | 910 |
| 2011 | 0 | — | 0 | 1,493 |
| 2012 | 2 | — | 0 | 1,573 |
| 2013 | 1 | — | 0 | 1,301 |
| 2014 | 0 | — | 0 | 890 |
| 2015 | 0 | — | 0 | 781 |
| 2016 | 1 | — | 0 | 539 |
| 2017 | 1 | — | 0 | 531 |
| 2018 | 0 | — | 0 | 534 |
| 2019 | 2 | — | 0 | 399 |
| 2020 | 0 | — | 0 | 313 |
| 2021 | 1 | — | 0 | 245 |
| 2022 | 25 | 87 | 0 | 254 |
| 2023 | 10 | 95 | 0 | 282 |
| 2024 | 10 | 57 | 0 | 243 |
| 2025 | 4 | 59 | 0 | 47 |
| 2026 | 5 | 68 | 0 | — |
What is it indicated for?
The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232509: Accu-Chek Safe-T-Pro Uno 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/K232509
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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