510(k) Report

510(k) · Cleared

Cleared

Kodak Ektachem Electrolyte Analyzer

K800054510(k) TraditionalCleared Feb 5, 198027-day reviewClass II21 CFR 862.1600

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

Eastman Kodak Company · CEM Electrode, Ion Specific, Potassium

Cleared on Feb 5, 1980 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Feb 5, 1980
Review
27 days
Class
Class II
Product code
CEM
Recalls
None
Predicates
0

5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared19801990200020102020
  1. This deviceK800054 Kodak Ektachem Electrolyte AnalyzerEastman Kodak Company · 1980
  2. Descendant · cites it directly · 4 of its ownK071801 Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S)…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK073157 Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK081411 Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2008 · Recalled
  5. Descendant · 4 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009
  6. Descendant · 5 generations on · 0 of its ownK093611 Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products…Ortho-Clinical Diagnostics, Inc. · 2010

Most influential descendants

Showing 5 of 5 · See all
  • K071801Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659Ortho-Clinical Diagnostics, Inc. · 2007 · cites it directly4descendants
  • K073157Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2007 · 2 generations on3descendants
  • K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc. · 2008 · 3 generations on2descendants
  • K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 4 generations on1descendant
  • K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2010 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K800054Kodak Ektachem Electrolyte AnalyzerEastman Kodak Company1980—
+1K071801Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207…Ortho-Clinical Diagnostics, Inc.20074
+2K073157Vitros Chemistry Products K+ Slides and Calibrator Kit 2Ortho-Clinical Diagnostics, Inc.20071
+3K081411Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2Ortho-Clinical Diagnostics, Inc.20084
+4K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator…Ortho-Clinical Diagnostics, Inc.2009—
+5K093611Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT…Ortho-Clinical Diagnostics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200810
200910
201010
FIG. 1 — Lineage of K800054, 1980–2010Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CEM? 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 CEM device

  1. #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (5)

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

NumberDeviceApplicantDecidedDescendants
K071801Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659Ortho-Clinical Diagnostics, Inc.20074

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?

  • Of its descendants, K071801 (Ortho-Clinical Diagnostics, Inc., 2007) has gone furthest, with 4 descendants of its own.

How does its category compare?

All CEM devices

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

FDA decisions per year · CEM

1in 2025

2007: 12009: 12010: 32011: 32012: 42020: 12023: 22025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEM

180in 2012

2010: 195 days median2011: 74 days median2012: 180 days median
2007high 195 (2010) · low 74 (2011)2026

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

Recalls per year · CEM

4in 2025

2008: 12010: 122011: 62016: 12019: 12020: 32021: 12023: 22025: 4
2007high 12 (2010) · low 0 (2007)2026

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

Adverse event reports per year · CEM

29in 2025

2007: 662008: 2452009: 792010: 1132011: 1262012: 452013: 372014: 42015: 72016: 62017: 322018: 132019: 252020: 272021: 182022: 162023: 302024: 422025: 29
2007high 245 (2008) · low 4 (2014)2025

MAUDE reports naming product code CEM, 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—066
20080—1245
20091—079
2010319512113
20113746126
20124180045
20130—037
20140—04
20150—07
20160—16
20170—032
20180—013
20190—125
20201—327
20210—118
20220—016
20232—230
20240—042
20251—429
20261—0—

More from Eastman Kodak Company

238 FDA decisions under this applicant name. See the company

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  • K060055Kodak PacsEastman Kodak Company · 2006
  • K053347Kodak Carestream PacsEastman Kodak Company · 2006

Recent decisions in CEM

The CEM category page

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  • K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2025
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  • K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. · 2020

https://510kreport.com/device/K800054 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800054: Kodak Ektachem Electrolyte Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800054

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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