510(k) Report

510(k) · Cleared

Recalled · 2011

Avoximeter 4000

K951485510(k) TraditionalCleared Nov 6, 1995221-day reviewClass I21 CFR 862.3220Recalls 2

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

A-Vox Systems, Inc. · JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

Cleared on Nov 6, 1995 after a 221-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
Nov 6, 1995
Review
221 days
Class
Class I
Product code
JKS
Recalls
2
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951485 Avoximeter 4000A-Vox Systems, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK050014 Hemonir TMNir Diagnostics, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all
  • K050014Hemonir TMNir Diagnostics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951485Avoximeter 4000A-Vox Systems, Inc.1995—
+1K050014Hemonir TMNir Diagnostics, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K951485, 1995–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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  • Recall history across each candidate’s familyin the report
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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K050014Hemonir TMNir Diagnostics, Inc.20050

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 23, 2011Not classifiedZ-2218-2011Device DesignAn incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
Feb 13, 2008Not classifiedZ-1239-2008Process designIncorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K050014 (Nir Diagnostics, Inc., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JKS devices

JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKS

FDA has decided no JKS device since 2007.

Median 510(k) review, days · JKS

Too few JKS 510(k)s in any year since 2007 to give a median.

Recalls per year · JKS

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKS

1in 2018

2015: 12018: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code JKS, 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—10
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from A-Vox Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K932954AvoximeterA-Vox Systems, Inc. · 1993
  • K922075AvoximeterA-Vox Systems, Inc. · 19923 recalls

Recent decisions in JKS

The JKS category page

  • K863825CO-Oximeter SolutionsD.R.G. Scientific Industries · 1986
  • K862253IL 482 CO-OximeterInstrumentation Laboratory CO · 1986
  • K853990OSM3 HemoximeterRadiometer America, Inc. · 1985
  • K833693Tee Adapter 9890-Flush Winding 282Shaban Mfg. Co. · 1983
  • K833211Bile Salts MixtureAcumedia Manufacturers, Inc. · 1983

https://510kreport.com/device/K951485 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951485: Avoximeter 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951485

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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