510(k) · Cleared

Cleared

Sentinel Iron Liquid

K051115510(k) TraditionalCleared Aug 25, 2005115-day reviewClass I21 CFR 862.1410

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

Sentinel Ch. Srl · JIY Photometric Method, Iron (Non-Heme)

Cleared on Aug 25, 2005 as substantially equivalent to K972363 (Instrumentation Laboratory CO, 1997) after a 115-day review. Its family tree reaches back 2 generations to 1987.

Decided: Aug 25, 2005
Review: 115 days
Class: Class I
Product code: JIY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K871973 (1987). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK871973 IL Monarch 1000 Clinical Chemistry Analytical Sys.Instrumentation Laboratory CO · 1987
1 generation backK972363 IL Test IronInstrumentation Laboratory CO · 1997
This deviceK051115 Sentinel Iron LiquidSentinel Ch. Srl · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K871973	IL Monarch 1000 Clinical Chemistry Analytical Sys.	Instrumentation Laboratory CO	1987	—
−1	K972363	IL Test Iron	Instrumentation Laboratory CO	1997	—
0 (this device)	K051115	Sentinel Iron Liquid	Sentinel Ch. Srl	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K051115, 1987–2005Source: 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 JIY? 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? (2)

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
*	K972363	IL Test Iron Summary page 2 …tic Assay Instrumentation Iron Liquid ILTest Iron Laboratory K972363 15 Aug 1997 Company Table 7.2 below report a comparison of…	Instrumentation Laboratory CO	1997	—
*	—	Roche UIBC Named without a submission number			—

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?

The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All JIY devices

JIY Photometric Method, Iron (Non-Heme): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIY

FDA has decided no JIY device since 2007.

Median 510(k) review, days · JIY

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

Recalls per year · JIY

1in 2025

2007high 8 (2009) · low 0 (2007)2026

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

Adverse event reports per year · JIY

7in 2025

2007high 15 (2012) · low 0 (2007)2025

MAUDE reports naming product code JIY, 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	—	0	0
2008	—	1	0
2009	—	8	0
2010	—	0	0
2011	—	0	0
2012	—	1	15
2013	—	1	2
2014	—	0	0
2015	—	0	0
2016	—	3	2
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	3
2021	—	0	2
2022	—	0	3
2023	—	2	6
2024	—	0	8
2025	—	1	7
2026	—	0	—

What is it indicated for?

The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only).

Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051115 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051115: Sentinel Iron Liquid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051115

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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