510(k) · Cleared

Cleared

Careside Analyzer

K980056510(k) TraditionalCleared Mar 6, 199859-day reviewClass I21 CFR 862.2170

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

Exigent Diagnostics, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on Mar 6, 1998 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 59-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Mar 6, 1998
Review: 59 days
Class: Class I
Product code: JJF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K912844 (1991). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
This deviceK980056 Careside AnalyzerExigent Diagnostics, Inc. · 1998
Descendant · cites it directly · 0 of its ownK993634 Careside AnalyzerCareside, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K993634Careside AnalyzerCareside, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912844	Kodak Ektachem Dtii System	Eastman Kodak Company	1991	—
0 (this device)	K980056	Careside Analyzer	Exigent Diagnostics, Inc.	1998	—
+1	K993634	Careside Analyzer	Careside, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K980056, 1991–1999Source: 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 JJF? 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? (1)

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
*	K912844	Kodak Ektachem Dtii System Summary page 1 …T 60 II/DTSC II Module. Name of Predicate Device: Johnson and Johnson’s Vitros DT 60 II/DTSC I/ (formerly Kodak Ektachem DT 60 II System) Predicate Device S10K number: K 912844/A Product Code: 751JE Exigent Diagnostics, Inc. Page 14a CareSide™ Analyzer Premarket Notification revised on…	Eastman Kodak Company	1991	—

Also cleared against K912844: 28 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K993634	Careside Analyzer	Careside, Inc.	1999	0

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?

Its one ancestor has no recall.
Of its descendants, K993634 (Careside, Inc., 1999) has gone furthest, with 0 descendants of its own.
28 other devices also cite its predicate K912844.

How does its category compare?

All JJF devices

JJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJF

FDA has decided no JJF device since 2007.

Median 510(k) review, days · JJF

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

Recalls per year · JJF

2in 2018

2007high 3 (2012) · low 0 (2008)2026

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

Adverse event reports per year · JJF

2in 2025

2007high 21 (2010) · low 0 (2015)2025

MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	10
2008	—	0	2
2009	—	0	3
2010	—	0	21
2011	—	0	19
2012	—	3	8
2013	—	0	1
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	2	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

For in vitro diagnostic use by professionals with Exigent Diagnostics Cartridges for the in vitro measurement of various clinical chemistry analytes in human blood.

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/K980056 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980056: Careside Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980056

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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