510(k) Report

510(k) · Cleared

Cleared

Pump/Blood Chemistry Monitor

K951739510(k) TraditionalCleared Feb 28, 1996320-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Via Medical Corp. · LZF Pump, Infusion, Analytical Sampling

Cleared on Feb 28, 1996 after a 320-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 28, 1996
Review
320 days
Class
Class II
Product code
LZF
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951739 Pump/Blood Chemistry MonitorVia Medical Corp. · 1996
  2. Descendant · cites it directly · 1 of its ownK162042 OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp. · 2017
  3. Descendant · 2 generations on · 0 of its ownK192785 OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp. · 2017 · cites it directly1descendant
  • K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951739Pump/Blood Chemistry MonitorVia Medical Corp.1996—
+1K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.2017—
+2K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202010
FIG. 1 — Lineage of K951739, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192785 OptiScanner® 5000 Glucose Monitoring Systemscore -0.9 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.20171

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?

  • Of its descendants, K162042 (Optiscan Biomedical Corp., 2017) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LZF devices

LZF Pump, Infusion, Analytical Sampling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZF

1in 2020

2017: 12020: 1
2007high 1 (2017) · low 0 (2007)2026

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

2020: 1
2007high 1 (2020) · low 0 (2007)2025

MAUDE reports naming product code LZF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20171—00
20180—00
20190—00
20201—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Via Medical Corp.

4 FDA decisions under this applicant name. See the company

  • K935778Via 1-01 Infusion Pump/Blood Chemistry SystemVia Medical Corp. · 1996
  • K922997Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.Via Medical Corp. · 19941 recall
  • K920438Via 1-01 Infusion Pump Blood Chemistry SystemVia Medical Corp. · 1993

Recent decisions in LZF

The LZF category page

  • K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation · 2020
  • K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp. · 2017
  • K011238Roda (Real Time Oxygen Dynamics Analysis) Monitoring SystemMetracor Technologies, Inc. · 2002
  • K922997Via 1-01 Infusion Pump/Blood Chem. Syst. -- Mod.Via Medical Corp. · 19941 recall
  • K920438Via 1-01 Infusion Pump Blood Chemistry SystemVia Medical Corp. · 1993

https://510kreport.com/device/K951739 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951739: Pump/Blood Chemistry Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951739

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026