510(k) Report

510(k) · Cleared

Cleared

Hemonir TM

K050014510(k) TraditionalCleared May 5, 2005122-day reviewClass II21 CFR 864.7500

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

Nir Diagnostics, Inc. · GLY Oximeter To Measure Hemoglobin

Cleared on May 5, 2005 as substantially equivalent to K853990 (Radiometer America, Inc., 1985) and 1 other predicate after a 122-day review. Its family tree reaches back 1 generation to 1985.

Decided
May 5, 2005
Review
122 days
Class
Class II
Product code
GLY
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K853990 (1985). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK853990 · OSM3 Hemoximeter · Radiometer America, Inc. · 198519851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K853990 · OSM3 Hemoximeter · Radiometer America, Inc. · 19850
  1. Root · 1 generation backK853990 OSM3 HemoximeterRadiometer America, Inc. · 1985
  2. This deviceK050014 Hemonir TMNir Diagnostics, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K853990OSM3 HemoximeterRadiometer America, Inc.1985—
0 (this device)K050014Hemonir TMNir Diagnostics, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K050014, 1985–2005Source: 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), 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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K853990OSM3 Hemoximeter
Summary page 1
…Classification Name: Oximeter to Measure Hemoglobin 3. PREDICATE DEVICES * OSM3 Hemoximeter Radiometer America, Inc. K853990 • AVOXimeter 4000 A-VOX Sytems, Inc. K951485 4. DEVICE DESCRIPTION HemoNiRLbT M i…
Radiometer America, Inc.1985—
*K951485Avoximeter 4000
Summary page 1
…VICES * OSM3 Hemoximeter Radiometer America, Inc. K853990 • AVOXimeter 4000 A-VOX Sytems, Inc. K951485 4. DEVICE DESCRIPTION HemoNiRLbT M is a small, portable, battery-powered system using rechargeable batteries to…
A-Vox Systems, Inc.19952

Also cleared against K853990: 3 other devices →

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?

  • 1 of the 2 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K853990.

How does its category compare?

All GLY devices

GLY Oximeter To Measure Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GLY

FDA has decided no GLY device since 2007.

Median 510(k) review, days · GLY

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

Recalls per year · GLY

No recall names GLY since 2007.

Adverse event reports per year · GLY

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code GLY, 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—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

HemoNIRLbTM is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methemoglobin and carboxyhemoglobin.

Indications for use as stated in the FDA summary.

Also cleared against K853990

3 other devices cite the same predicate.

  • K080238Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-OximeterMasimo Corporation · 20081 recall
  • K053477Masimo Set Rad 57 CM and M Pulse CO-OximetersMasimo Corporation · 2006
  • K042536Masimo Set Rad 57 Pulse CO-OximeterMasimo Corporation · 20051 recall

Recent decisions in GLY

The GLY category page

  • K993104Stat Profile Phox CO-Oximeter Analyzer, Nova CO-Oximeter Controls, Levels 1 and 2, Nova CO-Oximeter THB…Nova Biomedical Corp. · 1999
  • K955013Nova CO-Oximeter AnalyzerNova Biomedical Corp. · 1996
  • K952725MulticheckRadiometer America, Inc. · 1996
  • K895466Avl Model 912 CO-OxyliteAvl Scientific Corp. · 1989

https://510kreport.com/device/K050014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050014: Hemonir TM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050014

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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