510(k) · Cleared

Cleared

Ise Indirect NA, K, CL for Gen.2

K053165510(k) SpecialCleared Dec 14, 200530-day reviewClass II21 CFR 862.1665

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

Roche Diagnostics Corp. · JGS Electrode, Ion Specific, Sodium

Cleared on Dec 14, 2005 as substantially equivalent to K953239 (Boehringer Mannheim Corp., 1995) after a 30-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Dec 14, 2005
Review: 30 days
Class: Class II
Product code: JGS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953239 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
This deviceK053165 Ise Indirect NA, K, CL for Gen.2Roche Diagnostics Corp. · 2005
Descendant · cites it directly · 0 of its ownK132418 Cobas C 501 Ise Indirect NA, K, CL for Gen. 2Roche Diagnostics · 2013

Most influential descendants

Showing 1 of 1 · See all

K132418Cobas C 501 Ise Indirect NA, K, CL for Gen. 2Roche Diagnostics · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953239	Boehringer Mannheim/Hitachi 917 Analyzer	Boehringer Mannheim Corp.	1995	18
0 (this device)	K053165	Ise Indirect NA, K, CL for Gen.2	Roche Diagnostics Corp.	2005	—
+1	K132418	Cobas C 501 Ise Indirect NA, K, CL for Gen. 2	Roche Diagnostics	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K053165, 1995–2013Source: 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 JGS? 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 JGS device

#1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 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
*	K953239	Boehringer Mannheim/Hitachi 917 Analyzer Summary page 2 …d diabetic acidosis. Predicate We claim substantial equivalence to the predicate device, original ISE Na, K, Device Cl, cleared in K953239. Continued on next page Confidential…	Boehringer Mannheim Corp.	1995	18

Also cleared against K953239: 4 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
K132418	Cobas C 501 Ise Indirect NA, K, CL for Gen. 2	Roche Diagnostics	2013	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 a recall.
Of its descendants, K132418 (Roche Diagnostics, 2013) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K953239.

How does its category compare?

All JGS devices

JGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JGS

3in 2023

2007high 4 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JGS

347in 2023

2007high 347 (2023) · low 58 (2019)2026

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

Recalls per year · JGS

4in 2023

2007high 7 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JGS

64in 2025

2007high 912 (2011) · low 3 (2008)2025

MAUDE reports naming product code JGS, 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	0	—	7	33
2008	2	—	1	3
2009	2	—	0	57
2010	1	—	1	361
2011	3	191	1	912
2012	1	—	2	412
2013	2	—	5	510
2014	1	—	0	251
2015	1	—	1	158
2016	4	198	0	84
2017	1	—	0	292
2018	3	180	0	158
2019	3	58	5	105
2020	2	—	1	89
2021	0	—	1	91
2022	1	—	0	60
2023	3	347	4	98
2024	0	—	0	96
2025	0	—	0	64
2026	1	—	0	—

What is it indicated for?

The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease…

Read the full statement (126 words)

The ISE module of the Roche / Hitachi systems is intended for the quantitative determination of sodium, potassium, and chloride in serum, plasma, or urine using ion-selective electrodes.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053165: Ise Indirect NA, K, CL for Gen.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053165

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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