510(k) · Cleared
Recalled · Class II · 2025Prestige Coil System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bait USA, LLC · KRD Device, Vascular, For Promoting Embolization
Cleared on Apr 8, 2022 as substantially equivalent to K200030 (Balt USA, LLC, 2020) after a 29-day review. Its family tree reaches back 24 generations to 1995. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 8, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- KRD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 24 generations to K951256 (1995). 66 ancestors in all, the oldest K860840 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 24 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 20 generations between
- 3 generations backK151760 Barricade Embolization Coil SystemBlockade Medical · 2015
- 2 generations backK172390 Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa) · 2018 · Recalled
- 1 generation backK200030 Optima Coil SystemBalt USA, LLC · 2020 · Recalled
- This deviceK220699 Prestige Coil SystemBait USA, LLC · 2022
- Descendant · cites it directly · 0 of its ownK251383 Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC · 2025
Show all 24 generations
- Root · 24 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 23 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 22 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 21 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 20 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 19 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 18 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 17 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 16 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 15 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 14 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 13 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- 12 generations backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- 11 generations backK112226 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011
- 10 generations backK113457 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011
- 9 generations backK120908 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2012
- 8 generations backK123338 Barricade Embolization Coil SystemBlockade Medical · 2013
- 7 generations backK131475 Barricade Embolization Coil SystemBlockade Medical · 2013
- 6 generations backK132482 Barricade Embolization Coil SystemBlockade Medical · 2013
- 5 generations backK140104 Barricade Embolization Coil SystemBlockade Medical · 2014
- 4 generations backK142513 Barricade Embolization Coil SystemBlockade Medical · 2014
- 3 generations backK151760 Barricade Embolization Coil SystemBlockade Medical · 2015
- 2 generations backK172390 Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa) · 2018 · Recalled
- 1 generation backK200030 Optima Coil SystemBalt USA, LLC · 2020 · Recalled
- This deviceK220699 Prestige Coil SystemBait USA, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −23 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −22 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −21 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −20 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −19 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −18 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −17 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −16 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −15 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −14 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −13 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| −12 | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
| −11 | K112226 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2011 | — |
| −10 | K113457 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2011 | — |
| −9 | K120908 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2012 | — |
| −8 | K123338 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| −7 | K131475 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| −6 | K132482 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| −5 | K140104 | Barricade Embolization Coil System | Blockade Medical | 2014 | — |
| −4 | K142513 | Barricade Embolization Coil System | Blockade Medical | 2014 | — |
| −3 | K151760 | Barricade Embolization Coil System | Blockade Medical | 2015 | — |
| −2 | K172390 | Optima Coil System | Blockade Medical, LLC (D.B.A. Balt Usa) | 2018 | 4 |
| −1 | K200030 | Optima Coil System | Balt USA, LLC | 2020 | 5 |
| 0 (this device) | K220699 | Prestige Coil System | Bait USA, LLC | 2022 | — |
| +1 | K251383 | Prestige Coil System (Prestige Packing Line Extension) | Balt USA, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 |
|---|---|---|---|
| * | K200030 | Optima Coil SystemSummary page 4…egulation Name: Device, Vascular, for Promoting Embolization Device Classification: Class II Predicate Device: Prestige Coil System, 510(k)#: K200030 Originally cleared under trade name Optima Coil System Device Description: The Prestige Coil System… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251383 | Prestige Coil System (Prestige Packing Line Extension) | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2025 | Class II | Z-1989-2025 | Vendor change control | Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. |
| Jan 3, 2024 | Class II | Z-1042-2024 | Material/Component Contamination | Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 15 of the 66 ancestors have a recall of any class.
- Of its descendants, K251383 (Balt USA, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200030.
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. 2022, 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 Prestige Coil 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/K220699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220699: Prestige 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/K220699
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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