510(k) · Cleared
ClearedVascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable Coil Sysem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HCG Device, Neurovascular Embolization
Cleared on Jan 25, 2013 as substantially equivalent to K964367 (Cordis Neurovascular, Inc., 1997) and 6 other predicates after a 67-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Jan 25, 2013
- Review
- 67 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K891688 (1989). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 3 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 2 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 1 generation backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- This deviceK123560 Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS…Codman & Shurtleff, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −3 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −2 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −1 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| 0 (this device) | K123560 | Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit… | Codman & Shurtleff, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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? (7)
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 |
|---|---|---|---|
| * | K964367 | Ces Vascular Occlusion SystemSummary page 1…Product Predicate For: Concurrence Date Code Vascular Codman & K964367 HCG Intended Use Occlusion Shurtleff, Inc January 30, 1997… | 1997 |
| * | K972881 | Ces Vascular Occlusion SystemSummary page 1…Manufacturing _______________Sterilization Vascular Codman & K972881 HCG Intended Use Occlusion Shurtleff, Inc June 4, 1998… | 1998 |
| * | K983483 | Vascular Occlusion SystemSummary page 1…Manufacturing ______________ _______________Sterilization Vascular Codman & K983483 HCG Intended Use Design Occlusion Shurtleff, Inc March 24, 1999… | 1999 |
| * | K030963 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as the Trufill DCS…Summary page 2…___________Concurrence Date Code ________ TRUFILL DCS Codman & K030963 HCG Intended Use ORBIT Shurtleff, Inc June… | 2003 |
| * | K032553 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as Trufill DCS…Summary page 2…___________________Sterilization TRUFILL DCS Codman & K032553 HCG Intended Use ORBIT Shurtleff, Inc Septe… | 2003 |
| * | K053197 | Trufill DCS Orbit Detachable Coil System Line ExtensionSummary page 2…Sterilization TRUFILL DCS Codman & K053 197 HCG Intended Use ORBIT Shurtleff, Inc Decemb… | 2005 |
| * | K080967 | Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe or Trufill DCS Syringe II…Summary page 2…______________ ______________ _________________Sterilization TRUFILL DCS Codman & K080967 HCG Intended Use OR-BIT Shurtleff, Inc May 2… | 2008 |
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 24 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K964367.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions df the brain, spinal cord and spine.
The TRUFILL DOS ORBIT Detachable Coil System is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DOS ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123560: Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable Coil Sysem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123560
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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