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 Jul 12, 2018 as substantially equivalent to K150281 (Nova Biomedical Corporation, 2015) after an 84-day review. Its family tree reaches back 3 generations to 2006. 1 of the 9 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Jul 12, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- PZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K060345 (2006). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK060345 Nova Statstrip Glucose Hospital Meter, Statstrip Control SolutionsNova Biomedical Corp. · 2006 · Recalled
- 2 generations backK132121 Statstrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2014
- 1 generation backK150281 StatStrip Glucose Hospital MeterNova Biomedical Corporation · 2015
- This deviceK181043 StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2018
- Descendant · cites it directly · 0 of its ownK252323 cobas pulse blood glucose monitoring systemRoche Diagnostics · 2026
- Descendant · cites it directly · 0 of its ownK232075 StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2024 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK182552 StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2018
- Descendant · cites it directly · 0 of its ownK182549 StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation · 2018
Class I recalls in this family
- K232075 StatStrip Glucose Hospital Meter Systemcites it directly · 2024
Most influential descendants
Showing 4 of 4 · See all- K252323cobas pulse blood glucose monitoring systemRoche Diagnostics · 2026 · cites it directly0descendants
- K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation · 2024 · cites it directly0descendants
- K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation · 2018 · cites it directly0descendants
- K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060345 | Nova Statstrip Glucose Hospital Meter, Statstrip Control Solutions | Nova Biomedical Corp. | 2006 | 3 |
| −2 | K132121 | Statstrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2014 | — |
| −1 | K150281 | StatStrip Glucose Hospital Meter | Nova Biomedical Corporation | 2015 | — |
| 0 (this device) | K181043 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2018 | — |
| +1 | K252323 | cobas pulse blood glucose monitoring system | Roche Diagnostics | 2026 | — |
| +1 | K232075 | StatStrip Glucose Hospital Meter System | Nova Biomedical Corporation | 2024 | Class I |
| +1 | K182552 | StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation | 2018 | — |
| +1 | K182549 | StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation | 2018 | — |
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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K150281 | StatStrip Glucose Hospital MeterSummary page 4…ass Prescription Use Blood Glucose Meter For 75 PZI 862.1345 II Near-Patient Testing Predicate Device: StatStrip Glucose Hospital Meter System, K150281. Device Description: The StatStrip Glucose Hospital Meter System was previously cleared under K150281. The purpose of this dual… | 2015 |
What descends from it? (4)
4 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 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K252323 (Roche Diagnostics, 2026) has gone furthest, with 0 descendants of its own.
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. 2018, 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 throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. The system should only be…
Read the full statement (106 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 throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or nconate heel stick.
It is not intended for use with nconate 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/K181043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181043: 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/K181043
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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