510(k) · Cleared
ClearedRuby XL System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Mar 14, 2025 as substantially equivalent to K173614 (Penumbra, Inc., 2018) after a 60-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Mar 14, 2025
- Review
- 60 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K951256 (1995). 37 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations between
- 3 generations backK103305 Penumbra Embolization Coil SystemPenumbra, Inc. · 2011 · Recalled
- 2 generations backK120330 Penumbra Coil System/Penumbra Coil 400Penumbra, Inc. · 2012
- 1 generation backK173614 Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc. · 2018
- This deviceK250079 Ruby XL SystemPenumbra, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 7 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 6 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 5 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 4 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 3 generations backK103305 Penumbra Embolization Coil SystemPenumbra, Inc. · 2011 · Recalled
- 2 generations backK120330 Penumbra Coil System/Penumbra Coil 400Penumbra, Inc. · 2012
- 1 generation backK173614 Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc. · 2018
- This deviceK250079 Ruby XL SystemPenumbra, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −10 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −7 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −6 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −5 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −4 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −3 | K103305 | Penumbra Embolization Coil System | Penumbra, Inc. | 2011 | 1 |
| −2 | K120330 | Penumbra Coil System/Penumbra Coil 400 | Penumbra, Inc. | 2012 | — |
| −1 | K173614 | Penumbra Coil 400, Ruby Coil System, POD System | Penumbra, Inc. | 2018 | — |
| 0 (this device) | K250079 | Ruby XL System | Penumbra, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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 |
|---|---|---|---|
| * | K173614 | Penumbra Coil 400, Ruby Coil System, POD SystemSummary page 5…ces 510(k) Number Name of Device Predicate Penumbra Coil System (Penumbra Coil 400 and Ruby Coil K173614 System) and POD System… | 2018 |
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 30 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 37 ancestors have a recall of any class.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250079: Ruby XL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250079
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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