510(k) Report

510(k) · Cleared

Recalled · 2003

Avl Omni Analyzer

K972733510(k) TraditionalCleared Sep 9, 199750-day reviewClass II21 CFR 862.1345Recalls 6

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

Avl Scientific Corp. · CGA Glucose Oxidase, Glucose

Cleared on Sep 9, 1997 as substantially equivalent to K954612 (Radiometer America, Inc., 1995) and 3 other predicates after a 50-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 6 times.

Decided
Sep 9, 1997
Review
50 days
Class
Class II
Product code
CGA
Recalls
6
Predicates
4

Its longest line of descent runs back 1 generation to K946206 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 2 other ancestors1995: 1 other ancestorK946206 · Ciba Corning 8-- Series CO-Oximeter · Ciba Corning Diagnostics Corp. · 199519961998
Other ancestors, by generation 1 generation back: 3 other ancestors K946206 · Ciba Corning 8-- Series CO-Oximeter · Ciba Corning Diagnostics Corp. · 19950
  1. Root · 1 generation backK946206 Ciba Corning 8-- Series CO-OximeterCiba Corning Diagnostics Corp. · 1995
  2. This deviceK972733 Avl Omni AnalyzerAvl Scientific Corp. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K946206Ciba Corning 8-- Series CO-OximeterCiba Corning Diagnostics Corp.1995—
0 (this device)K972733Avl Omni AnalyzerAvl Scientific Corp.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199620
FIG. 1 — Lineage of K972733, 1995–1997Source: 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.

Planning a device in CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K954612Abl System 625, 615, 605
Summary page 1
…Analyzers.' Specifically: Radiometer 625 CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY HEMATOLOGY HEMATOLOGY HEMATOLOGY HEMATOLOGY CHEMISTRY CHEMISTRY [K954612], NOVA Biomedical ULTRA [K960120], Chiron 865 [K946206] and Instrumentation Laboratories BGGE [K955793]. 510(k)…
Radiometer America, Inc.19951
*K960120Stat Profile Ultra F,G,H,I,J, and K Analyzers
Summary page 1
…eter 625 CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY HEMATOLOGY HEMATOLOGY HEMATOLOGY HEMATOLOGY CHEMISTRY CHEMISTRY [K954612], NOVA Biomedical ULTRA [K960120], Chiron 865 [K946206] and Instrumentation Laboratories BGGE [K955793]. 510(k) Summary AVL OMNI Combi Analyzer…
Nova Biomedical Corp.1996—
*K946206Ciba Corning 8-- Series CO-Oximeter
Summary page 1
…EMISTRY CHEMISTRY CHEMISTRY CHEMISTRY CHEMISTRY HEMATOLOGY HEMATOLOGY HEMATOLOGY HEMATOLOGY CHEMISTRY CHEMISTRY [K954612], NOVA Biomedical ULTRA [K960120], Chiron 865 [K946206] and Instrumentation Laboratories BGGE [K955793]. 510(k) Summary AVL OMNI Combi Analyzer (4) Description of th…
Ciba Corning Diagnostics Corp.1995—
*K955793IL Bgge Blood Gas with Glucose System
Summary page 1
…EMATOLOGY HEMATOLOGY HEMATOLOGY HEMATOLOGY CHEMISTRY CHEMISTRY [K954612], NOVA Biomedical ULTRA [K960120], Chiron 865 [K946206] and Instrumentation Laboratories BGGE [K955793]. 510(k) Summary AVL OMNI Combi Analyzer (4) Description of the new device The AVL OMNI™ Analyzer is a fully-a…
Instrumentation Laboratory CO1996—

Also cleared against K954612: 1 other device →

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

DateClassRecallRoot causeReason
Dec 29, 2003Not classifiedZ-0336-04OtherThe firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003Not classifiedZ-0335-04OtherThe firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003Not classifiedZ-0337-04OtherThe firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 15, 2003Not classifiedZ-0326-04OtherIf the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
Dec 15, 2003Not classifiedZ-0328-04OtherIf the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
Dec 15, 2003Not classifiedZ-0327-04OtherIf the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

The 5 latest of 6 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 4 ancestors has a recall of any class.
  • 1 other device also cites its predicate K954612.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

What is it indicated for?

The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO₂, PO₂, ctHb, HHb, O₂Hb, COHb, MetHb, SulfHb, Na⁺, K⁺, Cl, ionized Ca™, Hematocrit, glucose and lactate in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K954612

1 other device cites the same predicate.

  • K033060Calibrating Material, Calibrating StandardsDiamond Diagnostics, Inc. · 2004

More from Avl Scientific Corp.

33 FDA decisions under this applicant name. See the company

  • K001632Opti-Check Plus Multi-Analyte Control, Model HC7009Avl Scientific Corp. · 2000
  • K000103Avl Opti R AnalyzerAvl Scientific Corp. · 2000
  • K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
  • K990092Avl Omni Modular AnalyzerAvl Scientific Corp. · 19994 recalls
  • K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998

Recent decisions in CGA

The CGA category page

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  • K210933YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
  • K220328EasyStat 300Medica Corporation · 2024
  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
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https://510kreport.com/device/K972733 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972733: Avl Omni Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972733

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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