510(k) Report

510(k) · Cleared

Recalled · 2003

Avl Omni Analyzer

K954018510(k) TraditionalCleared Oct 5, 199541-day reviewClass II21 CFR 864.5620Recalls 8

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

Avl Scientific Corp. · GKR System, Hemoglobin, Automated

Cleared on Oct 5, 1995 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 8 times.

Decided
Oct 5, 1995
Review
41 days
Class
Class II
Product code
GKR
Recalls
8
Predicates
0

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

FIG. 1 — Lineage of K954018Source: FDA 510(k) database · 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.

Planning a device in GKR? 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 GKR device

  1. #1 K201217 HemoCue Hb 301 Systemscore 0.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
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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?

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-0330-04OtherThe firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003Not classifiedZ-0331-04OtherThe firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003Not classifiedZ-0333-04OtherThe firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003Not classifiedZ-0334-04OtherThe firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003Not classifiedZ-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-0332-04OtherThe 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.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GKR devices

GKR System, Hemoglobin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKR

2in 2020

2008: 12009: 12011: 12013: 22017: 12018: 22019: 12020: 2
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKR

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

Recalls per year · GKR

1in 2013

2010: 12011: 12013: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GKR

1in 2024

2008: 22009: 162010: 92011: 122012: 252013: 432014: 312015: 192016: 92019: 92020: 12021: 12022: 12024: 1
2007high 43 (2013) · low 0 (2007)2025

MAUDE reports naming product code GKR, 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
20081—02
20091—016
20100—19
20111—112
20120—025
20132—143
20140—031
20150—019
20160—09
20171—00
20182—00
20191—09
20202—01
20210—01
20220—01
20230—00
20240—01
20250—00
20260—0—

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 GKR

The GKR category page

  • K201217HemoCue Hb 301 SystemHemocue AB · 2020
  • K200909Hemo Control (optional Add Pack Hemo Control DM)Ekf-Diagnostic GmbH · 2020
  • K181751HemoCue Hb 801 SystemHemocue AB · 2019
  • K182298hemochroma PLUS SystemImmunostics Inc., · 2018
  • K172173DiaSpect Tm, DiaSpect Tm CuvettesEkf-Diagnostic GmbH · 2018

https://510kreport.com/device/K954018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954018: Avl Omni Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954018

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