510(k) · Cleared

Cleared

Avl Opti Critical Care Analyzer

K993837510(k) TraditionalCleared Dec 16, 199934-day reviewClass II21 CFR 862.1345

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 Dec 16, 1999 as substantially equivalent to K981426 (Nova Biomedical Corp., 1998) and 11 other predicates after a 34-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.

Decided: Dec 16, 1999
Review: 34 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 12

Its longest line of descent runs back 5 generations to K861087 (1986). 22 ancestors in all, the oldest K823480 (1983). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
4 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
3 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
2 generations backK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
1 generation backK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
This deviceK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
Descendant · cites it directly · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
Descendant · 2 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021

Most influential descendants

Showing 2 of 2 · See all

K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · cites it directly1descendant
K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K861087	Avl Model 983 Electrolyte Analyzer	Avl Scientific Corp.	1986	—
−4	K961458	Avl 9180 Electrolyte Analyzer	Avl Scientific Corp.	1996	1
−3	K972673	Avl 9181 Electrolyte Analyzer	Avl Scientific Corp.	1997	7
−2	K974784	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	1998	—
−1	K984299	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	1998	—
0 (this device)	K993837	Avl Opti Critical Care Analyzer	Avl Scientific Corp.	1999	—
+1	K131126	Opti Cca-TS2	Opti Medical Systems, Inc.	2013	—
+2	K200986	OPTI® B-Lac Cassette	Opti Medical Systems, Inc.	2021	—

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	4	0
1996	2	0
1998	2	0
1999	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K993837, 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 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 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (12)

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
*	K981426	Stat Profile Ultra F,G,H,I,J,K, and L Analyzers Summary page 1 …ion, safety and efficacy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOV A Biomedical STAT Profile [K981426], Chiron 865 [K946206], AVL OMNI [K990092], SenDx 100 [954482], Diametrics IRMA [981270], I-STAT 200 [940918], as well as electro…	Nova Biomedical Corp.	1998	—
*	K946206	Ciba Corning 8-- Series CO-Oximeter Summary page 1 …cy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOV A Biomedical STAT Profile [K981426], Chiron 865 [K946206], AVL OMNI [K990092], SenDx 100 [954482], Diametrics IRMA [981270], I-STAT 200 [940918], as well as electrolyte analyzers such as…	Ciba Corning Diagnostics Corp.	1995	—
*	K990092	Avl Omni Modular Analyzer Summary page 1 …rrently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOV A Biomedical STAT Profile [K981426], Chiron 865 [K946206], AVL OMNI [K990092], SenDx 100 [954482], Diametrics IRMA [981270], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] a…	Avl Scientific Corp.	1999	4
*	K954482	Sendx 100 PH, Blood Gas & Electrolyte Analysis System Summary page 1 …ces known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: NOV A Biomedical STAT Profile [K981426], Chiron 865 [K946206], AVL OMNI [K990092], SenDx 100 [954482], Diametrics IRMA [981270], I-STAT 200 [940918], as well as electrolyte analyzers such as AVL 9181 [972763] and IL 943 Flame Phot…	Cirrus Medical,Inc.	1995	—
*	K981270	Irma Blood Analysis System Summary page 1 …ers' and 'Point of Care' analyzers, Specifically: NOV A Biomedical STAT Profile [K981426], Chiron 865 [K946206], AVL OMNI [K990092], SenDx 100 [954482], Diametrics IRMA [981270], 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.	1998	—
*	K940918	I-Stat 200 Portable Clinical Analyzer Summary page 1 …re' analyzers, Specifically: NOV A Biomedical STAT Profile [K981426], Chiron 865 [K946206], AVL OMNI [K990092], SenDx 100 [954482], Diametrics IRMA [981270], 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 …MNI [K990092], SenDx 100 [954482], Diametrics IRMA [981270], 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, K974784, 98429…	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, K974784, 984299]. Description of the new device The AVL OPTI Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in,…	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, K974784, 984299]. 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],…	Avl Scientific Corp.	1996	—
*	K974784	Avl Opti Critical Care Analyzer Summary page 1 …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, K974784, 984299]. 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], instrumen…	Avl Scientific Corp.	1998	—
*	K984299	Avl Opti Critical Care Analyzer Summary page 1 …[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, K974784, 984299]. 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	—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131126	Opti Cca-TS2	Opti Medical Systems, Inc.	2013	1

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 13 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
6 of the 22 ancestors have a recall of any class.
Of its descendants, K131126 (Opti Medical Systems, Inc., 2013) has gone furthest, with 1 descendant of its own.

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

2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	122	2	29
2008	6	56	2	37
2009	10	155	4	75
2010	8	122	6	172
2011	9	217	3	423
2012	10	123	0	233
2013	3	441	3	172
2014	5	265	2	122
2015	4	150	6 (2)	155
2016	4	157	2	36
2017	2	—	0	92
2018	2	—	0	69
2019	2	—	1	116
2020	2	—	0	68
2021	1	—	0	48
2022	1	—	0	272
2023	4	249	3	1,141
2024	2	—	0	266
2025	0	—	0	59
2026	1	—	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*, CI', Ca™", glucose and BUN 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/K993837 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993837: Avl Opti Critical Care Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993837

Report an extraction error

Are you the manufacturer?

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