510(k) · Cleared
ClearedAssure Titanium Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Cleared on May 23, 2022 as substantially equivalent to K132121 (Nova Biomedical Corporation, 2014) after a 788-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- May 23, 2022
- Review
- 788 days
- Class
- Class II
- Product code
- PZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060345 (2006). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK060345 Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsNova Biomedical Corp. · 2006 · Recalled
- 1 generation backK132121 Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014
- This deviceK200788 Assure Titanium Blood Glucose Monitoring SystemArkray, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK221349 XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions | Nova Biomedical Corp. | 2006 | 3 |
| −1 | K132121 | Statstrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2014 | — |
| 0 (this device) | K200788 | Assure Titanium Blood Glucose Monitoring System | Arkray, Inc. | 2022 | — |
| +1 | K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | Taidoc Technology Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 PZI? 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 PZI device
- #1 K252323 cobas pulse blood glucose monitoring systemscore 12.4 · 4 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 |
|---|---|---|---|
| * | K132121 | Statstrip Glucose Hospital Meter SystemSummary page 5…me 510(k) Number StatStrip Glucose Hospital Meter System K132121 4. Device Description The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered meter, disposabl… | 2014 |
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 |
|---|---|---|---|
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring System | 2024 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K221349 (Taidoc Technology Corporation, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132121.
How does its category compare?
All PZI devicesPZI Prescription Use Blood Glucose Meter For Near-Patient Testing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PZI
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PZI
816in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PZI
5so far in 2026, the most since 2007
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · PZI
35in 2025
MAUDE reports naming product code PZI, 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 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 87 | 0 | 0 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 1 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 3 | 816 | 1 (1) | 5 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 1 | — | 5 (5) | — |
What is it indicated for?
The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing or skilled nursing facilities, for multiple patient use.…
Read the full statement (137 words)
The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing or skilled nursing facilities, for multiple patient use. This system should only be used with single use, auto-disabling lancing devices for drawing finger stick capillary blood.
The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The system is not intended for use in acute care or hospital settings.
The system is not intended for neonatal use.
The system is for prescription use only.
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/K200788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200788: Assure Titanium Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200788
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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