510(k) · Decided
Recalled · Class II · 2013Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Via Medical Corp. · LZF Pump, Infusion, Analytical Sampling
Cleared on Jan 11, 1994 after a 568-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.
- Decided
- Jan 11, 1994
- Review
- 568 days
- Class
- Class II
- Product code
- LZF
- Recalls
- 1
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2013 | Class II | Z-1531-2013 | Device Design | International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an… |
No ancestor or descendant has a Class I 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.
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 | — |
https://510kreport.com/device/K922997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922997: Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922997
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026