510(k) · Cleared
ClearedFleximarc, Model CM-0.9-2-10-GG-L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortex Manufacturing, Inc. · IYE Accelerator, Linear, Medical
Cleared on Feb 24, 2010 after a 26-day review. The FDA summary names its predicate without a number. 2 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.
- Decided
- Feb 24, 2010
- Review
- 26 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 4 citing it directly. 2 of the 34 devices in this family, counting this one, have a Class I recall.
- This deviceK100267 Fleximarc, Model CM-0.9-2-10-GG-LCortex Manufacturing, Inc. · 2010
- Descendant · cites it directly · 25 of its ownK102506 Mixed Media MarkerCortex Manufacturing, Inc. · 2011
- Descendant · 2 generations on · 15 of its ownK120804 Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013
- Descendant · 3 generations on · 13 of its ownK153044 Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016
- Descendant · 4 generations on · 12 of its ownK163541 Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017
- Descendant · 2 generations on · 7 of its ownK143484 BioZorb MarkerFocal Therapeutics · 2015 · Recalled (Class I)
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K102506Mixed Media MarkerCortex Manufacturing, Inc. · 2011 · cites it directly25descendants
- K120804Cianna Medical Tissue Marker and Delivery SystemCianna Medical · 2013 · 2 generations on15descendants
- K153044Sentimag System, Sentimark Magnetic Marker SystermEndomagnetics Ltd., · 2016 · 3 generations on13descendants
- K163541Magseed Magnetic Marker SystemEndomagnetics Ltd., · 2017 · 4 generations on12descendants
- K143484BioZorb MarkerFocal Therapeutics · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100267 | Fleximarc, Model CM-0.9-2-10-GG-L | Cortex Manufacturing, Inc. | 2010 | — |
| +1 | K102506 | Mixed Media Marker | Cortex Manufacturing, Inc. | 2011 | — |
| +2 | K120804 | Cianna Medical Tissue Marker and Delivery System | Cianna Medical | 2013 | — |
| +3 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm | Endomagnetics Ltd., | 2016 | — |
| +4 | K163541 | Magseed Magnetic Marker System | Endomagnetics Ltd., | 2017 | — |
| +2 | K143484 | BioZorb Marker | Focal Therapeutics | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 3 | 2 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 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.
2 devices in this family have a Class I recall. 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | — | Visicoil, RadioMed (an IBA Co.) Named without a submission number |
What descends from it? (33)
See all 334 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K102506 (Cortex Manufacturing, Inc., 2011) has gone furthest, with 25 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarc can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100267: Fleximarc, Model CM-0.9-2-10-GG-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100267
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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