510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Opti Lion Electrolyte Analyzer, Model GD7200

K052027510(k) TraditionalCleared Sep 29, 200564-day reviewClass II21 CFR 862.1170Recalls 4

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

Osmetech, Inc. · CGZ Electrode, Ion-Specific, Chloride

Cleared on Sep 29, 2005 as substantially equivalent to K974784 (Avl Scientific Corp., 1998) and 7 other predicates after a 64-day review. Its family tree reaches back 5 generations to 1986. It has been recalled 4 times.

Decided
Sep 29, 2005
Review
64 days
Class
Class II
Product code
CGZ
Recalls
4
Predicates
8

Its longest line of descent runs back 5 generations to K861087 (1986). 23 ancestors in all, the oldest K823480 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1995: 6 other ancestors1990: 1 other ancestor1985: 1 other ancestor1996: 2 other ancestors1994: 3 other ancestors1988: 1 other ancestor1983: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestorK861087 · Avl Model 983 Electrolyte Analyzer · Avl Scientific Corp. · 1986K961458 · Avl 9180 Electrolyte Analyzer · Avl Scientific Corp. · 1996 · recalledK972673 · Avl 9181 Electrolyte Analyzer · Avl Scientific Corp. · 1997 · recalledK974784 · Avl Opti Critical Care Analyzer · Avl Scientific Corp. · 1998K984299 · Avl Opti Critical Care Analyzer · Avl Scientific Corp. · 1998198019851990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 10 other ancestors3 generations back: 3 other ancestors K984299 · Avl Opti Critical Care Analyzer · Avl Scientific Corp. · 1998K974784 · Avl Opti Critical Care Analyzer · Avl Scientific Corp. · 1998K972673 · Avl 9181 Electrolyte Analyzer · Avl Scientific Corp. · 1997 · recalledK961458 · Avl 9180 Electrolyte Analyzer · Avl Scientific Corp. · 1996 · recalledK861087 · Avl Model 983 Electrolyte Analyzer · Avl Scientific Corp. · 1986−50
  1. Root · 5 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
  2. 4 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
  3. 3 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
  4. 2 generations backK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  5. 1 generation backK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
  6. This deviceK052027 Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K861087Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp.1986—
−4K961458Avl 9180 Electrolyte AnalyzerAvl Scientific Corp.19961
−3K972673Avl 9181 Electrolyte AnalyzerAvl Scientific Corp.19977
−2K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp.1998—
−1K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp.1998—
0 (this device)K052027Opti Lion Electrolyte Analyzer, Model GD7200Osmetech, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198610
198710
198810
199010
199430
199560
199620
199910
FIG. 1 — Lineage of K052027, 1986–2005Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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 CGZ? 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? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K974784Avl Opti Critical Care Analyzer
Summary page 1
…fety and efficacy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: OPTI CCA [K974784, K984299, and K852473 1, Roche OMNI [K945915, K990092], electrolyte analyzers such as AVL 995 [K895317] and AVI, 91…
Avl Scientific Corp.1998—
*K984299Avl Opti Critical Care Analyzer
Summary page 1
…efficacy to a number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: OPTI CCA [K974784, K984299, and K852473 1, Roche OMNI [K945915, K990092], electrolyte analyzers such as AVL 995 [K895317] and AVI, 9180 [97276…
Avl Scientific Corp.1998—
*K852473Ion-Specific Electrode Option for Cobas Fara
Summary page 1
…number of currently marketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: OPTI CCA [K974784, K984299, and K852473 1, Roche OMNI [K945915, K990092], electrolyte analyzers such as AVL 995 [K895317] and AVI, 9180 [972763] and…
Roche Diagnostic Systems, Inc.1985—
*K945915Avl Omni Analyzer
Summary page 1
…rketed devices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: OPTI CCA [K974784, K984299, and K852473 1, Roche OMNI [K945915, K990092], electrolyte analyzers such as AVL 995 [K895317] and AVI, 9180 [972763] and the chemistry a…
Avl Scientific Corp.19959
*K990092Avl Omni Modular Analyzer
Summary page 1
…vices known as 'Combi Analyzers' and 'Point of Care' analyzers, Specifically: OPTI CCA [K974784, K984299, and K852473 1, Roche OMNI [K945915, K990092], electrolyte analyzers such as AVL 995 [K895317] and AVI, 9180 [972763] and the chemistry analyzer s…
Avl Scientific Corp.19994
*K895317Avl Model 995HB PH/Blood Gas Analyzer
Summary page 1
…re' analyzers, Specifically: OPTI CCA [K974784, K984299, and K852473 1, Roche OMNI [K945915, K990092], electrolyte analyzers such as AVL 995 [K895317] and AVI, 9180 [972763] and the chemistry analyzer such as Roche Diagnostics Cobas Integra IK951595]. The…
Avl Scientific Corp.1990—
*K972673Avl 9181 Electrolyte Analyzer
Our reading of the summary gave 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 9180”.
Avl Scientific Corp.19977
*K951595Roche Cobas Integra Analyzer, Reagent Cassettes
Summary page 1
…], electrolyte analyzers such as AVL 995 [K895317] and AVI, 9180 [972763] and the chemistry analyzer such as Roche Diagnostics Cobas Integra IK951595]. The OPTI LION is modified design of the OPTI Critical Care Analyzer [K974784, K984299 and K852473]…
Roche Diagnostic Systems, Inc.19957

Also cleared against K974784: 2 other devices →

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
Aug 9, 2013Class IIZ-0029-2014Error in labelingOPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer…
Mar 15, 2011Not classifiedZ-2558-2011Nonconforming Material/ComponentThe values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
Apr 20, 2009Not classifiedZ-1083-2010Process controlOuter box labeling shows an incorrect storage temperature range.
Jul 18, 2007Not classifiedZ-0119-2008Device DesignIncorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 8 of the 23 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K974784.

How does its category compare?

All CGZ devices

CGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGZ

1in 2018

2007: 12008: 22016: 12017: 12018: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGZ

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

Recalls per year · CGZ

2in 2019

2007: 12008: 12009: 12011: 12019: 2
2007high 2 (2019) · low 0 (2010)2026

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

Adverse event reports per year · CGZ

5in 2025

2007: 42009: 12010: 72011: 52012: 302013: 422014: 102015: 22016: 12017: 22018: 192019: 32020: 32022: 52023: 92024: 62025: 5
2007high 42 (2013) · low 0 (2008)2025

MAUDE reports naming product code CGZ, 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
20071—14
20082—10
20090—11
20100—07
20110—15
20120—030
20130—042
20140—010
20150—02
20161—01
20171—02
20181—019
20190—23
20200—03
20210—00
20220—05
20230—09
20240—06
20250—05
20260—0—

What is it indicated for?

The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the

measurement of sodium, potassium, chloride, ionized calcium and pH in

samples of whole blood, serum and plasma as appropriate in either a traditional

clinical laboratory setting or point-of-care locations by personnel minimally

qualified to perform and report these results.

Indications for use as stated in the FDA summary.

Also cleared against K974784

2 other devices cite the same predicate.

  • K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
  • K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998

More from Osmetech, Inc.

2 FDA decisions under this applicant name. See the company

  • K061730Osmetech Opti R Critical Care Analyzer, Model GD7044Osmetech, Inc. · 2006

Recent decisions in CGZ

The CGZ category page

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  • K170320Alinity c ICT Sample DiluentAbbott Laboratories · 2017
  • K162020VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics · 20162 recalls
  • K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131…Ortho-Clinical Diagnostics, Inc. · 2008
  • K070889Autodelfia Neonatal Irt L Kit, Model B022-112Wallac OY · 2008

https://510kreport.com/device/K052027 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052027: Opti Lion Electrolyte Analyzer, Model GD7200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052027

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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