510(k) Report

FDA applicant

Avl Scientific Corp.

Roswell, GA33 decisions1982–200021 recalls

FDA records 33 decisions for Avl Scientific Corp. (Roswell, GA) from 1982 to 2000: 33 510(k) clearances. Most are in product codes CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…) and JFP (Electrode, Ion Specific, Calcium). Its devices cite 50 predicates, 23 of them its own earlier devices. 21 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Avl Scientific Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Avl Scientific Corp. since 2007.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Avl Scientific Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph12decisions
  • JFPElectrode, Ion Specific, Calcium4decisions
  • CEMElectrode, Ion Specific, Potassium3decisions
  • JGSElectrode, Ion Specific, Sodium3decisions
  • CGAGlucose Oxidase, Glucose2decisions
  • JJYMulti-Analyte Controls, All Kinds (Assayed)2decisions

Also: JJR (1), GLY (1), GZJ (1), JIX (1), JJC (1), GKR (1).

Whose devices does it build on?

Its devices cite 50 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 times; 23 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K972673Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 19977cite it
  • K961458Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 19966cite it
  • K895317Avl Model 995HB PH/Blood Gas AnalyzerAvl Scientific Corp. · 19906cite it
  • K990092Avl Omni Modular AnalyzerAvl Scientific Corp. · 19994cite it
  • K944089Avl Opti PH/Blood Gas AnalyzerAvl Scientific Corp. · 19943cite it
  • K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 19983cite it

What has FDA decided for it lately?

  • 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
  • K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  • K974822Avl Opti-Check PH/ Blood Gas/ Electrolyte/THB/ SO2 ControlAvl Scientific Corp. · 1998
  • K972733Avl Omni AnalyzerAvl Scientific Corp. · 19976 recalls

All 33 as Avl Scientific Corp. →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K9614589180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of…Jan 6, 2021Class II
  • K932642Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the…Dec 21, 2004
  • K932642AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180…Dec 21, 2004
  • K932642Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled…Dec 21, 2004
  • K932642Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer Assembled…Dec 21, 2004
  • K932642Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled…Dec 21, 2004