510(k) · Cleared
Cleared1.5T 16CH Flex Speeder Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocoil, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jun 15, 2012 as substantially equivalent to K113474 (Neocoil, LLC, 2012) after a 39-day review. Its family tree reaches back 2 generations to 2010. 4 later devices descend from it.
- Decided
- Jun 15, 2012
- Review
- 39 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K101632 (2010). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK101632 MetaflexcoilNeocoil, LLC · 2010
- 1 generation backK113474 1.5T Gem Flex CoilNeocoil, LLC · 2012
- This deviceK121362 1.5T 16CH Flex Speeder LargeNeocoil, LLC · 2012
- Descendant · cites it directly · 0 of its ownK244054 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large…Quality Electrodynamics · 2025
- Descendant · cites it directly · 0 of its ownK141832 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, LargeNeocoil, LLC · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK133422 1.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, LargeNeocoil, LLC · 2013
- Descendant · cites it directly · 0 of its ownK123272 1.5T 16CH Flex Speeder Large, 1.5T 16CH Flex Speeder MediumNeocoil, LLC · 2013
Most influential descendants
Showing 4 of 4 · See all- K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)Quality Electrodynamics · 2025 · cites it directly0descendants
- K1418323T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, LargeNeocoil, LLC · 2014 · cites it directly0descendants
- K1334221.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, LargeNeocoil, LLC · 2013 · cites it directly0descendants
- K1232721.5T 16CH Flex Speeder Large, 1.5T 16CH Flex Speeder MediumNeocoil, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K101632 | Metaflexcoil | Neocoil, LLC | 2010 | — |
| −1 | K113474 | 1.5T Gem Flex Coil | Neocoil, LLC | 2012 | — |
| 0 (this device) | K121362 | 1.5T 16CH Flex Speeder Large | Neocoil, LLC | 2012 | — |
| +1 | K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T… | Quality Electrodynamics | 2025 | — |
| +1 | K141832 | 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large | Neocoil, LLC | 2014 | 1 |
| +1 | K133422 | 1.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, Large | Neocoil, LLC | 2013 | — |
| +1 | K123272 | 1.5T 16CH Flex Speeder Large, 1.5T 16CH Flex Speeder Medium | Neocoil, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K113474 | 1.5T Gem Flex CoilSummary page 1…roton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. 5.7. Predicate Device * 1.5T GEM Flex Coil (K1 13474) 5.8. Comparison to Predicate The NeoCil 1.5T l6ch Flex SPEEDER coils are identical in physical, performance… | 2012 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | 2025 | 0 |
| K141832 | 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large | 2014 | 0 |
| K133422 | 1.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, Large | 2013 | 0 |
| K123272 | 1.5T 16CH Flex Speeder Large, 1.5T 16CH Flex Speeder Medium | 2013 | 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 2 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K244054 (Quality Electrodynamics, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K113474.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
To be used in conjunction with Toshiba Magnetic Resonance Scanners with DL96 connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121362: 1.5T 16CH Flex Speeder Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121362
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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