510(k) · Cleared

Recalled · 2003

Avl Omni Analyzer

K945915510(k) TraditionalCleared Apr 5, 1995124-day reviewClass I21 CFR 862.2150Recalls 9

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

Avl Scientific Corp. · JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

Cleared on Apr 5, 1995 after a 124-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 9 times.

Decided: Apr 5, 1995
Review: 124 days
Class: Class I
Product code: JJC
Recalls: 9
Predicates: 0

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

This deviceK945915 Avl Omni AnalyzerAvl Scientific Corp. · 1995
Descendant · cites it directly · 0 of its ownK052027 Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc. · 2005 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945915	Avl Omni Analyzer	Avl Scientific Corp.	1995	—
+1	K052027	Opti Lion Electrolyte Analyzer, Model GD7200	Osmetech, Inc.	2005	4

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K945915, 1995–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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?

FDA has not posted a summary or statement for it, 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.

Number	Device	Applicant	Decided	Descendants
K052027	Opti Lion Electrolyte Analyzer, Model GD7200	Osmetech, Inc.	2005	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 29, 2003	Not classified	Z-0330-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0331-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0333-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0334-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0336-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0332-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0335-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0337-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
Dec 29, 2003	Not classified	Z-0329-04	Other	The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K052027 (Osmetech, Inc., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJC devices

JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJC

FDA has decided no JJC device since 2007.

Median 510(k) review, days · JJC

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

Recalls per year · JJC

No recall names JJC since 2007.

Adverse event reports per year · JJC

7in 2015

2007high 62 (2009) · low 0 (2016)2025

MAUDE reports naming product code JJC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	8
2008	—	4
2009	—	62
2010	—	41
2011	—	22
2012	—	3
2013	—	8
2014	—	8
2015	—	7
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K945915 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945915: 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/K945915

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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