510(k) · Cleared

Cleared

Confirma Breast Mri Interventional Components

K071534510(k) TraditionalCleared Jul 9, 200734-day reviewClass II21 CFR 892.1000

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

Confirma, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jul 9, 2007 as substantially equivalent to K001303 (Mri Devices Corp., 2000) and 3 other predicates after a 34-day review. Its family tree reaches back 2 generations to 2000.

Decided: Jul 9, 2007
Review: 34 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 4

Its longest line of descent runs back 2 generations to K000832 (2000). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK000832 Sterotactic Localization Device (SLD)Philips Medical Systems North America, Inc. · 2000
1 generation backK020289 Mics Intervention Aid, Catalog # Mics-Mia and Mics-MiasMachnet BV · 2002
This deviceK071534 Confirma Breast Mri Interventional ComponentsConfirma, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000832	Sterotactic Localization Device (SLD)	Philips Medical Systems North America, Inc.	2000	—
−1	K020289	Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias	Machnet BV	2002	—
0 (this device)	K071534	Confirma Breast Mri Interventional Components	Confirma, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	2	0
2005	2	0

FIG. 1 — Lineage of K071534, 2000–2007Source: 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 MOS? 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 MOS device

#1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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? (4)

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
*	K001303	Breast Immobilization Device MR-by 160 Summary page 3 …k) Product Regulation No. Trade Name Manufacturer Code Number K001303 Breast Immobilization MRI Devices 90 MOS 892.1000 Device MR-BY 160 Corporatio…	Mri Devices Corp.	2000	—
*	K020289	Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias Summary page 3 …r Code Number K001303 Breast Immobilization MRI Devices 90 MOS 892.1000 Device MR-BY 160 Corporation K020289 MICS Intervention Aid Machnet BV 90 LNH 892.1000 K052704 Model BBD Breast Invivo Cor…	Machnet BV	2002	—
*	K052704	Model BBD Breast Immobilization and Biopsy Device Summary page 3 …90 MOS 892.1000 Device MR-BY 160 Corporation K020289 MICS Intervention Aid Machnet BV 90 LNH 892.1000 K052704 Model BBD Breast Invivo Corporation 90 MOS 892.1000 Immobilization and Biopsy Devic…	Invivo Corp.	2005	—
*	K052987	Breast Immobilization and Biopsy Device, Models BI 160-O, BI 160-PA and BI 160-CC Summary page 3 …90 LNH 892.1000 K052704 Model BBD Breast Invivo Corporation 90 MOS 892.1000 Immobilization and Biopsy Device K052987 Breast Immobilization and Noras R6ntgen-und 90 MOS 892.1000 Biopsy Device, Models BI Medizintec…	Noras Rontgen-Und Medizintechnik GmbH	2005	—

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 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
1 of the 7 ancestors has a recall of any class.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

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

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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	16	19	0	4
2008	19	33	2	2
2009	10	43	0	5
2010	16	78	1	13
2011	25	57	0	7
2012	15	49	1	12
2013	7	87	0	10
2014	12	60	0	4
2015	6	58	2	5
2016	11	42	0	7
2017	9	63	0	9
2018	10	30	0	7
2019	3	178	8	8
2020	5	51	1	2
2021	4	41	0	3
2022	11	79	0	5
2023	10	59	0	4
2024	10	39	13	8
2025	3	59	0	2
2026	10	45	0	—

What is it indicated for?

The Confirma Breast MRI Interventional Components are intended to be used in conjunction with a magnetic resonance scanner and the Confirma Access Breast Coil designs to permit MRI-guided interventional procedures, such as breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071534 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071534: Confirma Breast Mri Interventional Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071534

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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