510(k) · Cleared
ClearedTem 3000 Head Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mr Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 23, 2004 as substantially equivalent to K021330 (Usa Instruments, Inc., 2002) after an 11-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Apr 23, 2004
- Review
- 11 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002179 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002179 Magnetom Allegra SystemSiemens Medical Solutions USA, Inc. · 2000 · Recalled
- 1 generation backK021330 Magnetom Trio Quadrature TX/RX Head CoilUsa Instruments, Inc. · 2002
- This deviceK040937 Tem 3000 Head CoilMr Instruments, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK061281 Insight Head CoilInsight Neuroimaging Systems, LLC · 2006
Most influential descendants
Showing 1 of 1 · See all- K061281Insight Head CoilInsight Neuroimaging Systems, LLC · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002179 | Magnetom Allegra System | Siemens Medical Solutions USA, Inc. | 2000 | 2 |
| −1 | K021330 | Magnetom Trio Quadrature TX/RX Head Coil | Usa Instruments, Inc. | 2002 | — |
| 0 (this device) | K040937 | Tem 3000 Head Coil | Mr Instruments, Inc. | 2004 | — |
| +1 | K061281 | Insight Head Coil | Insight Neuroimaging Systems, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K021330 | Magnetom Trio Quadrature TX/RX Head CoilSummary page 2…MR INSTRUMENTS INC C. Identification of Legally Marketed Devices 1. Name: Magnetom Trio Head Coil 2. K Number: K021330 3. Date Cleared: July 25, 2002 D. Description of the Device The TEM 3000 Head Coil is a 15-element qua… | 2002 |
| * | — | USA Instruments 3T head coil Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061281 | Insight Head Coil | 2006 | 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K061281 (Insight Neuroimaging Systems, LLC, 2006) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K021330.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 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 TEM 3000 head coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000 head coil is designed for use with the Magnetom Trio 3.0 Tesla scanner manufactured by Siemens Medical Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040937: Tem 3000 Head Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040937
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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