510(k) · Cleared
Clearedcobas pulse blood glucose monitoring system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Cleared on Jun 12, 2026 as substantially equivalent to K181043 (Nova Biomedical Corporation, 2018) after a 322-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Jun 12, 2026
- Review
- 322 days
- Class
- Class II
- Product code
- PZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K060345 (2006). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK060345 Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsNova Biomedical Corp. · 2006 · Recalled
- 3 generations backK132121 Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014
- 2 generations backK150281 StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015
- 1 generation backK181043 StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018
- This deviceK252323 cobas pulse blood glucose monitoring systemRoche Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions | Nova Biomedical Corp. | 2006 | 3 |
| −3 | K132121 | Statstrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2014 | — |
| −2 | K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | 2015 | — |
| −1 | K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2018 | — |
| 0 (this device) | K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 K221349 XPER Technology PREMIUM Pro Blood Glucose…score 9.0 · 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 |
|---|---|---|---|
| * | K181043 | StatStrip Glucose Hospital Meter SystemSummary page 5…Testing Regulation Numbers 21 CFR 862.1345 – Glucose test system Predicate Devices StatStrip Glucose Hospital Meter System, K181043 Establishment Registration Roche Diagnostics GmbH Mannheim, Germany: 9610126… | 2018 |
| † | K060373 | Cobas 6000 Series System | 2006 |
| † | K191899 | Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions | 2019 |
| † | K220272 | cobas pulse blood glucose monitoring system | 2024 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K181043.
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. 2026, 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 cobas® pulse blood glucose monitoring system consists of the cobas® pulse instrument and the cobas® GLU test strips. This system is intended for in vitro diagnostic, point of care, multiple-patient use within professional healthcare settings, including patients receiving intensive medical intervention/therapy. The cobas® GLU test strips provide an in vitro diagnostic test that quantitatively measures glucose in venous whole blood, arterial whole…
Read the full statement (133 words)
The cobas® pulse blood glucose monitoring system consists of the cobas® pulse instrument and the cobas® GLU test strips.
This system is intended for in vitro diagnostic, point of care, multiple-patient use within professional healthcare settings, including patients receiving intensive medical intervention/therapy.
The cobas® GLU test strips provide an in vitro diagnostic test that quantitatively measures glucose in venous whole blood, arterial whole blood, neonate arterial whole blood, or neonate heel stick whole blood samples, on the cobas® pulse system.
For neonate heel stick, the system should only be used with single-use, auto-disabling lancing devices.
This system is not intended for use with capillary finger stick, neonate cord blood specimens or neonate venous specimens.
This system is not intended for screening or diagnosis of diabetes, but is indicated for use in determining dysglycemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252323 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252323: cobas pulse blood glucose monitoring system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252323
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026