510(k) · Cleared

Cleared

Avl Opti Critical Care Analyzer

K984299510(k) TraditionalCleared Dec 11, 199810-day reviewClass II21 CFR 862.1145

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

Avl Scientific Corp. · JFP Electrode, Ion Specific, Calcium

Cleared on Dec 11, 1998 as substantially equivalent to K874832 (Nova Biomedical Corp., 1988) and 10 other predicates after a 10-day review. Its family tree reaches back 4 generations to 1986. 4 later devices descend from it.

Decided: Dec 11, 1998
Review: 10 days
Class: Class II
Product code: JFP
Recalls: None
Predicates: 11

Its longest line of descent runs back 4 generations to K861087 (1986). 16 ancestors in all, the oldest K823480 (1983). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
3 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
2 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
1 generation backK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
This deviceK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
Descendant · cites it directly · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
Descendant · 2 generations on · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
Descendant · 3 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
Descendant · cites it directly · 0 of its ownK052027 Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc. · 2005 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · cites it directly2descendants
K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 2 generations on1descendant
K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 3 generations on0descendants
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
−4	K861087	Avl Model 983 Electrolyte Analyzer	Avl Scientific Corp.	1986	—
−3	K961458	Avl 9180 Electrolyte Analyzer	Avl Scientific Corp.	1996	1
−2	K972673	Avl 9181 Electrolyte Analyzer	Avl Scientific Corp.	1997	7
−1	K974784	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	1998	—
0 (this device)	K984299	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	1998	—
+1	K993837	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	1999	—
+2	K131126	Opti Cca-TS2	Opti Medical Systems, Inc.	2013	—
+3	K200986	OPTI® B-Lac Cassette	Opti Medical Systems, Inc.	2021	—
+1	K052027	Opti Lion Electrolyte Analyzer, Model GD7200	Osmetech, Inc.	2005	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1986	1	0
1987	1	0
1988	1	0
1990	1	0
1994	3	0
1995	3	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2005	1	0
2013	1	0
2021	1	0

FIG. 1 — Lineage of K984299, 1986–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JFP? 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 JFP device

#1 K230300 i-STAT CG8+ cartridge with the i-STAT 1 Systemscore 6.8 · 3 generations · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (11)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K874832	Nova Stat Profile 5 Analyzer + Quality Control Summary page 1 …n function, safety and efficacy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrol…	Nova Biomedical Corp.	1988	—
*	K946206	Ciba Corning 8-- Series CO-Oximeter Summary page 1 …efficacy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as…	Ciba Corning Diagnostics Corp.	1995	—
*	K895317	Avl Model 995HB PH/Blood Gas Analyzer Summary page 1 …er of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] a…	Avl Scientific Corp.	1990	—
*	K954482	Sendx 100 PH, Blood Gas & Electrolyte Analysis System Summary page 1 …ted devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Phot…	Cirrus Medical,Inc.	1995	—
*	K945240	Irma Blood Analysis System Summary page 1 …i Analyzers' and 'Point of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI…	Diametrics Medical, Inc.	1995	4
*	K940918	I-Stat 200 Portable Clinical Analyzer Summary page 1 …nt of Care' analyzers, Specifically: NOVA Biomedical STAT 5 [K874832], Chiron 865 [K946206], AVL 995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyz…	I-Stat Corp.	1994	19
*	K972673	Avl 9181 Electrolyte Analyzer Our OCR of the scanned summary read K972763, FDA’s number for Hemaprompt (Aerscher Diagnostics). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AVL 9181”.	Avl Scientific Corp.	1997	7
*	K823480	IL 943 Flame Photometer Summary page 1 …995 [K895317], SenDx 100 [954482], Diametrics IRMA [945240], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089, K961161 and K974784].…	Instrumentation Laboratory CO	1983	—
*	K944089	Avl Opti PH/Blood Gas Analyzer Summary page 1 …analyzers such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089, K961161 and K974784]. Description of the new device The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 Ib…	Avl Scientific Corp.	1994	—
*	K961161	Avl Opti 1 PH/Blood Gas Analyzer Summary page 1 …such as AVL 9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089, K961161 and K974784]. Description of the new device The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 Ibs], instr…	Avl Scientific Corp.	1996	—
*	K974784	Avl Opti Critical Care Analyzer Summary page 1 …9181 [972763] and IL 943 Flame Photometer [K823480]. The OPTI Critical Care Analyzer is an improved design of the AVL OPTI 1 pH/Blood Gas Analyzer [K944089, K961161 and K974784]. Description of the new device The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in, 10 Ibs], instrument using…	Avl Scientific Corp.	1998	—

Also cleared against K874832: 2 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993837	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	1999	2
K052027	Opti Lion Electrolyte Analyzer, Model GD7200	Osmetech, Inc.	2005	0

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?

The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
4 of the 16 ancestors have a recall of any class.
Of its descendants, K993837 (Avl Scientific Corp., 1999) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K874832.

How does its category compare?

All JFP devices

JFP Electrode, Ion Specific, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFP

1in 2023

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFP

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

Recalls per year · JFP

1in 2011

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JFP

40in 2025

2007high 40 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	1	5
2009	0	—	0	5
2010	0	—	0	2
2011	0	—	1	8
2012	0	—	0	0
2013	0	—	0	1
2014	0	—	0	1
2015	0	—	0	3
2016	1	—	0	0
2017	0	—	0	2
2018	0	—	0	5
2019	1	—	0	6
2020	1	—	0	6
2021	0	—	0	0
2022	0	—	0	6
2023	1	—	0	2
2024	0	—	0	8
2025	0	—	0	40
2026	0	—	0	—

What is it indicated for?

The AVL OPTI Critical Care Analyzer intended to be used for the measurement of pH, PCO,, PO,, ctHb, SO,, Na', K*, Cl and Ca™" in whole blood, serum, plasma and aqueous dialysate solutions as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

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

https://510kreport.com/device/K984299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984299: Avl Opti Critical Care Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984299

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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