510(k) · Cleared
ClearedFlex Body Speeder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quality Electrodynamics, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 8, 2020 as substantially equivalent to K193140 (Quality Electrodynamics, LLC, 2020) after a 41-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Apr 8, 2020
- Review
- 41 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933659 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK933659 Model #100GE1500 Lower Extrem Quad Detect Array CoilMedic, Inc. · 1993
- 5 generations backK022395 1.5T Scanmed PV ArrayMedic, Inc. · 2002
- 4 generations backK140606 1.5T Procure Array Coil, 3.0T Procure Array CoilResonance Innovations, LLC · 2014
- 3 generations backK142755 Siemens 3.0 Blanket Array CoilResonance Innovations, LLC · 2014
- 2 generations backK173446 Contour 24Quality Electrodynamics, LLC · 2017
- 1 generation backK193140 Flex Body SPEEDERQuality Electrodynamics, LLC · 2020
- This deviceK200477 Flex Body SpeederQuality Electrodynamics, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933659 | Model #100GE1500 Lower Extrem Quad Detect Array Coil | Medic, Inc. | 1993 | — |
| −5 | K022395 | 1.5T Scanmed PV Array | Medic, Inc. | 2002 | — |
| −4 | K140606 | 1.5T Procure Array Coil, 3.0T Procure Array Coil | Resonance Innovations, LLC | 2014 | — |
| −3 | K142755 | Siemens 3.0 Blanket Array Coil | Resonance Innovations, LLC | 2014 | — |
| −2 | K173446 | Contour 24 | Quality Electrodynamics, LLC | 2017 | — |
| −1 | K193140 | Flex Body SPEEDER | Quality Electrodynamics, LLC | 2020 | — |
| 0 (this device) | K200477 | Flex Body Speeder | Quality Electrodynamics, LLC | 2020 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K193140 | Flex Body SPEEDERSummary page 4…stic device (21 CFR 892.1000, Product Code MOS, Class II) 8. Predicate Device Flex Body SPEEDER manufactured by Quality Electrodynamics, LLC., K193140 9. Device Description The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resona… | 2020 |
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 3.1 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Flex Body SPEEDER is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200477: Flex Body Speeder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200477
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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