510(k) · Cleared

Cleared

Irma SL Blood Analysis System CR Cartridge

K030035510(k) TraditionalCleared Jun 25, 2003173-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

Diametrics Medical, Inc. · JFY Enzymatic Method, Creatinine

Cleared on Jun 25, 2003 as substantially equivalent to K875191 (Eastman Kodak Company, 1988) after a 173-day review. Its family tree reaches back 1 generation to 1988.

Decided: Jun 25, 2003
Review: 173 days
Class: Class II
Product code: JFY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K875191 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK875191 Kodak Ektachem DT Slides (CRSC)Eastman Kodak Company · 1988
This deviceK030035 Irma SL Blood Analysis System CR CartridgeDiametrics Medical, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K875191	Kodak Ektachem DT Slides (CRSC)	Eastman Kodak Company	1988	—
0 (this device)	K030035	Irma SL Blood Analysis System CR Cartridge	Diametrics Medical, Inc.	2003	—

FIG. 1 — Lineage of K030035, 1988–2003Source: 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 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 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K875191	Kodak Ektachem DT Slides (CRSC) Summary page 1 …os DT60 I1 Chemistry System / Vi tros CRSC DT Slides Prcdicatc Device 510(k) Number: K875191 Predicate Device Product Code: 75 JFY Substantial Equivalence Claim The E W A ' SL Blood Anal…	Eastman Kodak Company	1988	—

Also cleared against K875191: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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.
1 other device also cites its predicate K875191.

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

2007high 8 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JFY

59in 2009

2007high 193 (2007) · low 59 (2009)2026

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

Recalls per year · JFY

1in 2013

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	193	0	1
2008	4	170	2	4
2009	3	59	3	22
2010	0	—	3	22
2011	2	—	0	42
2012	0	—	0	24
2013	0	—	1	39
2014	2	—	0	4
2015	0	—	0	7
2016	1	—	0	16
2017	1	—	0	16
2018	2	—	0	34
2019	2	—	0	56
2020	0	—	0	34
2021	2	—	0	57
2022	0	—	0	9
2023	0	—	0	36
2024	0	—	0	34
2025	0	—	0	61
2026	1	—	0	—

What is it indicated for?

Creatinine measurements are used in the diagnosis and treatment of certain renal disease, and in monitoring renal dialysis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030035 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030035: Irma SL Blood Analysis System CR Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030035

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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