510(k) · Cleared
ClearedStatstrip Glucose Hospital Meter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Cleared on Sep 24, 2014 as substantially equivalent to K063821 (Nova Biomedical Corp., 2007) and 1 other predicate after a 441-day review. Its family tree reaches back 1 generation to 2006. 1 of the 15 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Sep 24, 2014
- Review
- 441 days
- Class
- Class II
- Product code
- PZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K060345 (2006). 2 ancestors in all. 12 later devices descend from it, 3 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK060345 Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsNova Biomedical Corp. · 2006 · Recalled
- This deviceK132121 Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014
- Descendant · cites it directly · 5 of its ownK150281 StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015
- Descendant · 2 generations on · 4 of its ownK181043 StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018
- Descendant · cites it directly · 3 of its ownK150461 StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2015
- Descendant · cites it directly · 1 of its ownK200788 Assure Titanium Blood Glucose Monitoring SystemArkray, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK152986 StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K232075 StatStrip Glucose Hospital Meter System3 generations on · 2024
Most influential descendants
Showing 5 of 12 · See all- K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015 · cites it directly5descendants
- K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018 · 2 generations on4descendants
- K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2015 · cites it directly3descendants
- K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc. · 2022 · cites it directly1descendant
- K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions | Nova Biomedical Corp. | 2006 | 3 |
| 0 (this device) | K132121 | Statstrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2014 | — |
| +1 | K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | 2015 | — |
| +2 | K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2018 | — |
| +1 | K150461 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2015 | — |
| +1 | K200788 | Assure Titanium Blood Glucose Monitoring System | Arkray, Inc. | 2022 | — |
| +2 | K152986 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2016 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 1 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K063821 | Nova Statstrip Glucose Hospital Meter SystemSummary page 6…Corporation StatStrip Blood Glucose Hospital Meter Summary of Technological Characteristics: The StatStrip Glucose Hospital Meter System is the same device cleared in K063821 and K060345 (Nova StatStrip Glucose Hospital Meter System) and has the same scientific technology. No changes have been made to t… | 2007 |
| * | K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsSummary page 6…StatStrip Blood Glucose Hospital Meter Summary of Technological Characteristics: The StatStrip Glucose Hospital Meter System is the same device cleared in K063821 and K060345 (Nova StatStrip Glucose Hospital Meter System) and has the same scientific technology. No changes have been made to the meter, th… | 2006 |
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
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. 2014, 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 StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood…
Read the full statement (133 words)
The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens.
The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
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/K132121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132121: Statstrip Glucose Hospital Meter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132121
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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