510(k) · Cleared
ClearedTrufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as Trufill DCS Orbit Detachable Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Neurovascular, Inc. · HCG Device, Neurovascular Embolization
Cleared on Sep 23, 2003 after a 35-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 38 devices in its family, counting itself, has a Class I recall. 37 later devices descend from it.
- Decided
- Sep 23, 2003
- Review
- 35 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 2 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- This deviceK032553 Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also…Cordis Neurovascular, Inc. · 2003
- Descendant · cites it directly · 35 of its ownK063653 Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation · 2007
- Descendant · 2 generations on · 32 of its ownK070707 Micrus Microcoil SystemMicrus Endovascular Corporation · 2007
- Descendant · 3 generations on · 31 of its ownK073442 Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008
- Descendant · 4 generations on · 22 of its ownK081465 Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…5 generations on · 2022
Most influential descendants
Showing 5 of 37 · See all- K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation · 2007 · cites it directly35descendants
- K070707Micrus Microcoil SystemMicrus Endovascular Corporation · 2007 · 2 generations on32descendants
- K073442Micrus Microcoil SystemsMicrus Endovascular Corporation · 2008 · 3 generations on31descendants
- K081465Axium Detachable Coil SystemMicro Therapeutics, Inc. · 2008 · 4 generations on22descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032553 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as… | Cordis Neurovascular, Inc. | 2003 | — |
| +1 | K063653 | Micrus Microcoil System, Cashmere Model SRC | Micrus Endovascular Corporation | 2007 | — |
| +2 | K070707 | Micrus Microcoil System | Micrus Endovascular Corporation | 2007 | — |
| +3 | K073442 | Micrus Microcoil Systems | Micrus Endovascular Corporation | 2008 | — |
| +4 | K081465 | Axium Detachable Coil System | Micro Therapeutics, Inc. | 2008 | 2 |
| +5 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 1 |
| 2023 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (37)
See all 372 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K063653 (Micrus Endovascular Corporation, 2007) has gone furthest, with 35 descendants of its own.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
The TRUFILL@DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:
1) very high-risk for management by traditional operative techniques
2) inoperable
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL@ DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.
The TRUFILL@DCS Syringe is indicated for use with the TRUFILLO family of Detachable Coils.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032553: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as Trufill DCS Orbit Detachable Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032553
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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