510(k) · Cleared

Cleared

Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2

K120591510(k) TraditionalCleared Apr 17, 201249-day reviewClass II21 CFR 862.1150

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

Diamond Diagnostics, Inc. · JIT Calibrator, Secondary

Cleared on Apr 17, 2012 as substantially equivalent to K040958 (Tokyo Boeki Medical System, Ltd., 2005) after a 49-day review. Its family tree reaches back 2 generations to 1985.

Decided: Apr 17, 2012
Review: 49 days
Class: Class II
Product code: JIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K851172 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK851172 Cobas MiraRoche Diagnostic Systems, Inc. · 1985
1 generation backK040958 Prestige Models 24I and 400 and MGC Model 240Tokyo Boeki Medical System, Ltd. · 2005
This deviceK120591 Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2Diamond Diagnostics, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K851172	Cobas Mira	Roche Diagnostic Systems, Inc.	1985	—
−1	K040958	Prestige Models 24I and 400 and MGC Model 240	Tokyo Boeki Medical System, Ltd.	2005	—
0 (this device)	K120591	Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2	Diamond Diagnostics, Inc.	2012	—

FIG. 1 — Lineage of K120591, 1985–2012Source: 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 JIT? 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
*	K040958	Prestige Models 24I and 400 and MGC Model 240 Summary page 3 …1 Predicate Device: Tokyo Boeki ISE Module Calibrators Predicate 510(k) number(s): K040958 -)mparison with predicate: Characteristics Diamond Calibrators for Tokyo Boeki ISE…	Tokyo Boeki Medical System, Ltd.	2005	—

Also cleared against K040958: 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?

The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 19.8 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K040958.

How does its category compare?

All JIT devices

JIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · JIT

7in 2017

2007high 10 (2014) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIT

28in 2017

2007high 140 (2013) · low 28 (2017)2026

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

Recalls per year · JIT

1in 2023

2007high 5 (2018) · low 0 (2008)2026

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

Adverse event reports per year · JIT

7in 2025

2007high 215 (2019) · low 0 (2007)2025

MAUDE reports naming product code JIT, 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	5	78	1	0
2008	6	46	0	0
2009	2	—	2	0
2010	6	65	0	3
2011	7	48	3	2
2012	2	—	3	10
2013	5	140	0	43
2014	10	33	2	9
2015	4	30	1	6
2016	4	33	0	3
2017	7	28	0	7
2018	0	—	5	8
2019	0	—	0	215
2020	0	—	2	12
2021	0	—	0	3
2022	0	—	0	4
2023	0	—	1	6
2024	0	—	0	17
2025	0	—	0	7
2026	0	—	1	—

What is it indicated for?

Diamond Calibrators for Tokyo Boeki ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na+, K+, and Cl-electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, and Sirrus instruments in both Human Serum and Human Urine modes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120591 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120591: Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120591

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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