510(k) · Cleared
ClearedSpeeder 1.5T Wrist Array Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 31, 2007 as substantially equivalent to K050622 (Mri Devices Corporation, 2005) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Oct 31, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K931008 (1993). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK931008 Model #QWH-63, Quadrature Wrist and Hand CoilMri Devices Corp. · 1993
- 2 generations backK972205 Alpha 7000 Quadrature Wrist CoilUsa Instruments, Inc. · 1997
- 1 generation backK031143 Alpha 5000 Wrist CoilUsa Instruments, Inc. · 2003
- This deviceK072935 Speeder 1.5T Wrist Array CoilQuality Electrodynamics · 2007
- Descendant · cites it directly · 1 of its ownK083014 Atlas Speeder Head/Cervical Coil, Model Mjah-137AToshiba America Medical Systems, In.C · 2008
- Descendant · 2 generations on · 0 of its ownK121910 Octave Speeder HeadToshiba Medical Systems Corporation, Japan · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931008 | Model #QWH-63, Quadrature Wrist and Hand Coil | Mri Devices Corp. | 1993 | — |
| −2 | K972205 | Alpha 7000 Quadrature Wrist Coil | Usa Instruments, Inc. | 1997 | — |
| −1 | K031143 | Alpha 5000 Wrist Coil | Usa Instruments, Inc. | 2003 | — |
| 0 (this device) | K072935 | Speeder 1.5T Wrist Array Coil | Quality Electrodynamics | 2007 | — |
| +1 | K083014 | Atlas Speeder Head/Cervical Coil, Model Mjah-137A | Toshiba America Medical Systems, In.C | 2008 | — |
| +2 | K121910 | Octave Speeder Head | Toshiba Medical Systems Corporation, Japan | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K050622 | HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array CoilSummary page 1…t Coil 5. Common name: Coil, magnetic resonance, specialty 6.Classification: 21 CFR 892.1 000 7. Equivalent Device HRW-63-8 Wrist Array Coil by MRI Devices, K050622 8. Device Description The 1.5T Wrist Array Coil is a six channel phased array receive only coil. The coil has a rigid enclos… | 2005 |
| * | K031143 | Alpha 5000 Wrist CoilSummary page 2…ces 510(k) # Device Manufacturer K050622 HRW-63-8 Wrist Array Coil MRI Devices K031143 Alpha 5000 Wrist Coil USA Instruments K972205 Alpha 7000 Wrist Coil… | 2003 |
| * | K972205 | Alpha 7000 Quadrature Wrist CoilSummary page 2…K050622 HRW-63-8 Wrist Array Coil MRI Devices K031143 Alpha 5000 Wrist Coil USA Instruments K972205 Alpha 7000 Wrist Coil USA Instruments The 1.5T Wrist Array Coil and predicate devices are designed… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083014 | Atlas Speeder Head/Cervical Coil, Model Mjah-137A | 2008 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K083014 (Toshiba America Medical Systems, In.C, 2008) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K050622.
How does its category compare?
All MOS devicesMOS 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
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?
For use with a 1.5T Toshiba Vantage magnetic resonance scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072935: Speeder 1.5T Wrist Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072935
Report an extraction error
Are you the manufacturer?
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