510(k) · Cleared
ClearedTrufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as the 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 Jun 20, 2003 after an 85-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jun 20, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK030963 Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also…Cordis Neurovascular, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK123560 Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS…Codman & Shurtleff, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK063254 The Trufill DCS Detachable Coil System; the Trufill DCS Orbit…Cordis Neurovascular, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See all- K123560Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…Codman & Shurtleff, Inc. · 2013 · cites it directly0descendants
- K063254The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil SystemCordis Neurovascular, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030963 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as the… | Cordis Neurovascular, Inc. | 2003 | — |
| +1 | K123560 | Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit… | Codman & Shurtleff, Inc. | 2013 | — |
| +1 | K063254 | The Trufill DCS Detachable Coil System; the Trufill DCS Orbit Detachable Coil… | Cordis Neurovascular, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 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 HCG? 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? (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 |
|---|---|---|---|
| * | — | TRUFILL DCS Detachable Coil System Named without a submission number |
What descends from it? (2)
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, K123560 (Codman & Shurtleff, Inc., 2013) has gone furthest, with 0 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 ORBITTM Detachable Coil is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:
a) very high risk for management by traditional operative techniques, or,
b) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL DCS ORBITM Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.
The TRUFILL@DCS Syringe is indicated for use with the TRUFILL@family of Detachable Coils.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030963: Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as the 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/K030963
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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