510(k) · Cleared
ClearedBerenstein Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · HCG Device, Neurovascular Embolization
Cleared on Aug 15, 1996 after a 90-day review. The FDA summary names its predicate without a number. 2 of the 204 devices in its family, counting itself, have a Class I recall. 203 later devices descend from it.
- Decided
- Aug 15, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
203 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.
- This deviceK961923 Berenstein CoilTarget Therapeutics · 1996
- Descendant · cites it directly · 202 of its ownK964112 Berenstein CoilTarget Therapeutics · 1997
- Descendant · 2 generations on · 150 of its ownK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- Descendant · 3 generations on · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- Descendant · 3 generations on · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- Descendant · 4 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
Showing 5 of 203 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 203 · See all- K964112Berenstein CoilTarget Therapeutics · 1997 · cites it directly202descendants
- K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…Target Therapeutics · 1997 · 2 generations on150descendants
- K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · 3 generations on138descendants
- K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · 3 generations on105descendants
- K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 4 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| +1 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| +2 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| +3 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| +3 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| +4 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 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 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? (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 |
|---|---|---|---|
| * | — | Target Therapeutics Platinum Occlusion Coils Named without a submission number | |
| * | — | Cook Embolization Coils Named without a submission number |
What descends from it? (203)
See all 2032 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 · 8 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K964112 (Target Therapeutics, 1997) has gone furthest, with 202 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?
Berenstein Coils are intended for the embolization of vascular malformations of the 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/K961923 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961923: Berenstein Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961923
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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