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 Corporation · LZF Pump, Infusion, Analytical Sampling
Cleared on Feb 5, 2020 as substantially equivalent to K162042 (Optiscan Biomedical Corp., 2017) after a 128-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 5, 2020
- Review
- 128 days
- Class
- Class II
- Product code
- LZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951739 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K162042 | OptiScanner 5000 Glucose Monitoring SystemSummary page 4…ng System Class: II 3. Predicate Device Information Trade Name: OptiScanner® 5000 Glucose Monitoring System (K162042) 510(k) Number: K162042 Common Name: Automated, in-line, bedside, glucose monitoring system Device Classific… | 2017 |
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 24 years and passes through 3 companies; a new generation was cleared every 21.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LZF devicesLZF Pump, Infusion, Analytical Sampling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K192785 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192785: OptiScanner® 5000 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/K192785
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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