510(k) · Cleared
ClearedFlexicoil - Malleable Receive-Only Surface Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Odin Medical Technologies, Ltd. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Apr 24, 2002 as substantially equivalent to K991243 (Odin Technologies, Ltd., 1999) and 1 other predicate after a 61-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Apr 24, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911642 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911642 | MRP-5000 and MRP-7000 Multiplanar Reconstruction | Hitachi Medical Systems America, Inc. | 1991 | — |
| −1 | K991243 | NORMA 10 | Odin Technologies, Ltd. | 1999 | — |
| 0 (this device) | K020601 | Flexicoil - Malleable Receive-Only Surface Coil | Odin Medical Technologies, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K991243 | NORMA 10Summary page 2…t 20692, Israel Tel. 972-4-9591010, Fax 972-4-9591011 510(k) Medical Device Name Applicant Name Product Code Number NORMA 10 surface coil Odin Medical K991243 | LNH Technologies Ltd. Phased Array Musculo - IGC-Medical K003366 | MOS Skeletal Flex Coil Package Advances, Inc. Additional… | 1999 |
| * | K003366 | Model 545PH Series: Phased Array Musculo-Skeletal Flex CoilSummary page 2…== 510(k) Medical Device Name Applicant Name Product Code Number NORMA 10 surface coil Odin Medical K991243 | LNH Technologies Ltd. Phased Array Musculo - IGC-Medical K003366 | MOS Skeletal Flex Coil Package Advances, Inc. Additional Substantial Equivalence Information is provided in the attached Subs… | 2000 |
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 11 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 4 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.
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?
A magnetic resonance diagnostic device is intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic resonance spectra, which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance.
The FlexiCoil - malleable receive-only surface coil expands the capability of the PoleStar N-10 MR Imaging System. It improves imaging of selected sections of the head and extremities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020601: Flexicoil - Malleable Receive-Only Surface Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020601
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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