510(k) · Cleared

Cleared

Cobas Mira

K851172510(k) TraditionalCleared May 2, 198541-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

Roche Diagnostic Systems, Inc. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on May 2, 1985 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided: May 2, 1985
Review: 41 days
Class: Class I
Product code: JJF
Recalls: None
Predicates: 0

5 later devices descend from it, 3 citing it directly.

This deviceK851172 Cobas MiraRoche Diagnostic Systems, Inc. · 1985
Descendant · cites it directly · 2 of its ownK040958 Prestige Models 24I and 400 and MGC Model 240Tokyo Boeki Medical System, Ltd. · 2005
Descendant · 2 generations on · 0 of its ownK120591 Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2Diamond Diagnostics, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK110520 Biolis 12ITokyo Boeki Medisys, Inc. · 2012
Descendant · cites it directly · 0 of its ownK070704 Trilogy AnalyzerDrew Scientific, Inc. · 2007
Descendant · cites it directly · 0 of its ownK964409 HCL - 200 Biochemistry AnalyzerHcl Laboratory Systems, Inc. · 1997

Most influential descendants

Showing 5 of 5 · See all

K040958Prestige Models 24I and 400 and MGC Model 240Tokyo Boeki Medical System, Ltd. · 2005 · cites it directly2descendants
K120591Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2Diamond Diagnostics, Inc. · 2012 · 2 generations on0descendants
K110520Biolis 12ITokyo Boeki Medisys, Inc. · 2012 · 2 generations on0descendants
K070704Trilogy AnalyzerDrew Scientific, Inc. · 2007 · cites it directly0descendants
K964409HCL - 200 Biochemistry AnalyzerHcl Laboratory Systems, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	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	—
+2	K120591	Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2	Diamond Diagnostics, Inc.	2012	—
+2	K110520	Biolis 12I	Tokyo Boeki Medisys, Inc.	2012	—
+1	K070704	Trilogy Analyzer	Drew Scientific, Inc.	2007	—
+1	K964409	HCL - 200 Biochemistry Analyzer	Hcl Laboratory Systems, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2005	1	0
2007	1	0
2012	2	0

FIG. 1 — Lineage of K851172, 1985–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040958	Prestige Models 24I and 400 and MGC Model 240	Tokyo Boeki Medical System, Ltd.	2005	2
K070704	Trilogy Analyzer	Drew Scientific, Inc.	2007	0
K964409	HCL - 200 Biochemistry Analyzer	Hcl Laboratory Systems, Inc.	1997	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?

Of its descendants, K040958 (Tokyo Boeki Medical System, Ltd., 2005) has gone furthest, with 2 descendants of its own.

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	—

https://510kreport.com/device/K851172 · printed Nov 6, 2026

Cite this page

510(k) Report. “K851172: Cobas Mira.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851172

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026