510(k) Report

510(k) · Cleared

Cleared

Kodak Ektachem DT Slides (CA)

K870035510(k) TraditionalCleared May 12, 1987127-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

Eastman Kodak Company · CID Alizarin Sulfonate, Calcium

Cleared on May 12, 1987 after a 127-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
May 12, 1987
Review
127 days
Class
Class II
Product code
CID
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2008: 1 descendant cleared2009: 2 descendants cleared2010: 1 descendant cleared1990200020102020
  1. This deviceK870035 Kodak Ektachem DT Slides (CA)Eastman Kodak Company · 1987
  2. Descendant · cites it directly · 4 of its ownK072443 Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK082099 Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2008
  4. Descendant · 3 generations on · 2 of its ownK083680 Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2009 · 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
  • K072443Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA AssayOrtho-Clinical Diagnostics, Inc. · 2007 · cites it directly4descendants
  • K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2008 · 2 generations on3descendants
  • K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2009 · 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)K870035Kodak Ektachem DT Slides (CA)Eastman Kodak Company1987—
+1K072443Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA AssayOrtho-Clinical Diagnostics, Inc.20071
+2K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc.2008—
+3K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator…Ortho-Clinical Diagnostics, Inc.20091
+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
200710
200810
200920
201010
FIG. 1 — Lineage of K870035, 1987–2010Source: 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.

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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? (5)

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

NumberDeviceApplicantDecidedDescendants
K072443Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA AssayOrtho-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, K072443 (Ortho-Clinical Diagnostics, Inc., 2007) has gone furthest, with 4 descendants of its own.

How does its category compare?

All CID devices

CID Alizarin Sulfonate, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CID

FDA has decided no CID device since 2007.

Median 510(k) review, days · CID

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

Recalls per year · CID

No recall names CID since 2007.

Adverse event reports per year · CID

No MAUDE report names CID since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K870035: Kodak Ektachem DT Slides (CA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870035

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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