510(k) Report

510(k) · Cleared

Cleared

Kodak Ektachem DT Slides (CRSC)

K875191510(k) TraditionalCleared Feb 24, 198869-day reviewClass II21 CFR 862.1225

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

Eastman Kodak Company · JFY Enzymatic Method, Creatinine

Cleared on Feb 24, 1988 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.

Decided
Feb 24, 1988
Review
69 days
Class
Class II
Product code
JFY
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2003: 1 descendant cleared2008: 1 descendant cleared2009: 2 descendants cleared2010: 1 descendant cleared1990200020102020
  1. This deviceK875191 Kodak Ektachem DT Slides (CRSC)Eastman Kodak Company · 1988
  2. Descendant · cites it directly · 5 of its ownK071216 Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK072443 Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK082099 Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2008
  5. Descendant · 4 generations on · 2 of its ownK083680 Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc. · 2009 · Recalled
  6. Descendant · 5 generations on · 1 of its ownK091861 Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT…Ortho-Clinical Diagnostics, Inc. · 2009

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 12007: 22008: 12009: 22010: 1
2003high 2 (2007) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K071216Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2007 · cites it directly5descendants
  • K072443Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA AssayOrtho-Clinical Diagnostics, Inc. · 2007 · 2 generations on4descendants
  • K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2008 · 3 generations on3descendants
  • K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc. · 2009 · 4 generations on2descendants
  • K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…Ortho-Clinical Diagnostics, Inc. · 2009 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K875191Kodak Ektachem DT Slides (CRSC)Eastman Kodak Company1988—
+1K071216Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator…Ortho-Clinical Diagnostics, Inc.20071
+2K072443Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA AssayOrtho-Clinical Diagnostics, Inc.20071
+3K082099Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT…Ortho-Clinical Diagnostics, Inc.2008—
+4K083680Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator…Ortho-Clinical Diagnostics, Inc.20091
+5K091861Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator…Ortho-Clinical Diagnostics, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200720
200810
200920
201010
FIG. 1 — Lineage of K875191, 1988–2010Source: 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 JFY? 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 JFY device

  1. #1 K252619 Qscheck Uisacrscore 12.4 · 6 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? (7)

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

NumberDeviceApplicantDecidedDescendants
K071216Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit…Ortho-Clinical Diagnostics, Inc.20075
K030035Irma SL Blood Analysis System CR CartridgeDiametrics Medical, Inc.20030

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, K071216 (Ortho-Clinical Diagnostics, Inc., 2007) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JFY devices

JFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JFY

2in 2021

2007: 82008: 42009: 32011: 22014: 22016: 12017: 12018: 22019: 22021: 22026 (partial year): 1
2007high 8 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFY

59in 2009

2007: 193 days median2008: 170 days median2009: 59 days median
2007high 193 (2007) · low 59 (2009)2026

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

Recalls per year · JFY

1in 2013

2008: 22009: 32010: 32013: 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JFY

61in 2025

2007: 12008: 42009: 222010: 222011: 422012: 242013: 392014: 42015: 72016: 162017: 162018: 342019: 562020: 342021: 572022: 92023: 362024: 342025: 61
2007high 61 (2025) · low 1 (2007)2025

MAUDE reports naming product code JFY, 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
2007819301
2008417024
2009359322
20100—322
20112—042
20120—024
20130—139
20142—04
20150—07
20161—016
20171—016
20182—034
20192—056
20200—034
20212—057
20220—09
20230—036
20240—034
20250—061
20261—0—

More from Eastman Kodak Company

238 FDA decisions under this applicant name. See the company

  • K060550Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386Eastman Kodak Company · 20063 recalls
  • K060137Kodak Eclipse Image Processing SoftwareEastman Kodak Company · 2006
  • K060079Kodak Model CR-7400 Digital Radiography SystemEastman Kodak Company · 2006
  • K060055Kodak PacsEastman Kodak Company · 2006
  • K053347Kodak Carestream PacsEastman Kodak Company · 2006

Recent decisions in JFY

The JFY category page

  • K252619Qscheck UisacrQstag, Inc. · 2026
  • K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics, Inc. · 2021
  • K193649Yumizen C1200 Creatinine PAPHoriba Abx Sas · 2021
  • K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
  • K183555GEM Premier ChemSTATInstrumentation Laboratory CO · 2019

https://510kreport.com/device/K875191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K875191: Kodak Ektachem DT Slides (CRSC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K875191

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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