510(k) · Cleared
Recalled · 2010Suresteppro/Surestepflexx Professional Blood Glucose Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescan, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Oct 24, 2002 after a 29-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Oct 24, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK023194 Suresteppro/Surestepflexx Professional Blood Glucose Management SystemLifescan, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK113314 Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113314Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemHmd Biomedical, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023194 | Suresteppro/Surestepflexx Professional Blood Glucose Management System | Lifescan, Inc. | 2002 | — |
| +1 | K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring System | Hmd Biomedical, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | — | SURESTEP PRO Blood Glucose Monitoring System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2010 | Not classified | Z-2028-2010 | Other | Products may provide inaccurate results at readings over 400 mg/dL |
| Sep 29, 2006 | Not classified | Z-0453-2007 | Other | Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113314 (Hmd Biomedical, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SURESTEP PRO and the SURESTEP FLEXX Professional Blood Glucose Management Systems are for in vitro diagnostic use for the quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. These systems can also be used by lay users at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023194: Suresteppro/Surestepflexx Professional Blood Glucose Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023194
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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