510(k) · Cleared
ClearedBerenstein Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · KRD Device, Vascular, For Promoting Embolization
Cleared on Feb 26, 1997 as substantially equivalent to K961923 (Target Therapeutics, 1996) after a 134-day review. Its family tree reaches back 1 generation to 1996. 2 of the 204 devices in its family, counting itself, have a Class I recall. 202 later devices descend from it.
- Decided
- Feb 26, 1997
- Review
- 134 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961923 (1996). 202 later devices descend from it, 2 citing it directly. 2 of the 204 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK961923 Berenstein CoilTarget Therapeutics · 1996
- This deviceK964112 Berenstein CoilTarget Therapeutics · 1997
- Descendant · cites it directly · 150 of its ownK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- Descendant · 2 generations on · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- Descendant · 2 generations on · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- Descendant · 3 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- Descendant · 2 generations on · 98 of its ownK993417 GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18…Boston Scientific, Target · 2000
Showing 5 of 202 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 202 · See all- K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics · 1997 · cites it directly150descendants
- K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · 2 generations on138descendants
- K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · 2 generations on105descendants
- K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 3 generations on103descendants
- K993417GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Boston Scientific, Target · 2000 · 2 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| 0 (this device) | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| +1 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| +2 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| +2 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| +3 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| +2 | K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi… | Boston Scientific, Target | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 10 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 13 | 0 |
| 2013 | 14 | 0 |
| 2014 | 11 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 8 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 2 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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.
2 devices in this family have 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 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? (2)
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 |
|---|---|---|---|
| * | K961923 | Berenstein CoilSummary page 1…identical in materials, performance, and design parameters to Target Therapeutics Berenstein Coils, cleared for commercial distribution for neuro vascular indications in K961923 and is similar to other Target Therapeutics occlusion coils cleared for use in the peripheral vasculature including 510(k) Notif… | 1996 |
| * | — | Target Therapeutics occlusion coils Named without a submission number |
What descends from it? (202)
See all 2022 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K213385GEMObsidio, Inc. · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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.
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?
Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964112: Berenstein Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964112
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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