510(k) · Cleared
ClearedOptiScanner 5000 Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optiscan Biomedical Corp. · LZF Pump, Infusion, Analytical Sampling
Cleared on Oct 16, 2017 as substantially equivalent to K951739 (Via Medical Corp., 1996) after a 448-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Oct 16, 2017
- Review
- 448 days
- Class
- Class II
- Product code
- LZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951739 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951739 Pump/Blood Chemistry MonitorVia Medical Corp. · 1996
- This deviceK162042 OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp. · 2017
- Descendant · cites it directly · 0 of its ownK192785 OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951739 | Pump/Blood Chemistry Monitor | Via Medical Corp. | 1996 | — |
| 0 (this device) | K162042 | OptiScanner 5000 Glucose Monitoring System | Optiscan Biomedical Corp. | 2017 | — |
| +1 | K192785 | OptiScanner® 5000 Glucose Monitoring System | Optiscan Biomedical Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 LZF? 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 LZF device
- #1 K192785 OptiScanner® 5000 Glucose Monitoring Systemscore -0.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K951739 | Pump/Blood Chemistry MonitorSummary page 5…Glucose Monitoring System Class: II PREDICATE DEVICE VIA Medical Pump/Blood Chemistry Monitor (K951739) SUBSTANTIALLY EQUIVALENT TO: The OptiScanner is substantially equivalent in intended use and technological features to the V… | 1996 |
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 |
|---|---|---|---|
| K192785 | OptiScanner® 5000 Glucose Monitoring System | 2020 | 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?
- Its one ancestor has no recall.
- Of its descendants, K192785 (Optiscan Biomedical Corporation, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZF devicesLZF Pump, Infusion, Analytical Sampling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LZF
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · LZF
Too few LZF 510(k)s in any year since 2007 to give a median.
Recalls per year · LZF
No recall names LZF since 2007.
Adverse event reports per year · LZF
1in 2020
MAUDE reports naming product code LZF, 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for
detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects
a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the
plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use
in determining dysglycemia. The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162042: OptiScanner 5000 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/K162042
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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