510(k) · Cleared
ClearedMetaflexcoil
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 Aug 24, 2010 after a 75-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Aug 24, 2010
- Review
- 75 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK101632 MetaflexcoilNeocoil, LLC · 2010
- Descendant · cites it directly · 6 of its ownK113474 1.5T Gem Flex CoilNeocoil, LLC · 2012
- Descendant · 2 generations on · 4 of its ownK121362 1.5T 16CH Flex Speeder LargeNeocoil, LLC · 2012
- Descendant · cites it directly · 1 of its ownK172222 8ch Flex SuiteShenzhen RF Tech Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK252179 GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M…Shenzhen RF Tech Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK244054 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large…Quality Electrodynamics · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K1134741.5T Gem Flex CoilNeocoil, LLC · 2012 · cites it directly6descendants
- K1213621.5T 16CH Flex Speeder LargeNeocoil, LLC · 2012 · 2 generations on4descendants
- K1722228ch Flex SuiteShenzhen RF Tech Co., Ltd. · 2017 · cites it directly1descendant
- K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…Shenzhen RF Tech Co., Ltd. · 2026 · 2 generations on0descendants
- K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)Quality Electrodynamics · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101632 | Metaflexcoil | Neocoil, LLC | 2010 | — |
| +1 | K113474 | 1.5T Gem Flex Coil | Neocoil, LLC | 2012 | — |
| +2 | K121362 | 1.5T 16CH Flex Speeder Large | Neocoil, LLC | 2012 | — |
| +1 | K172222 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | 2017 | — |
| +2 | K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T… | Shenzhen RF Tech Co., Ltd. | 2026 | — |
| +3 | K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T… | Quality Electrodynamics | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K113474 (Neocoil, LLC, 2012) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 hii conjunction with a 1.5T GE HD or DV series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, 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/K101632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101632: Metaflexcoil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101632
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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