510(k) · Cleared
ClearedCook Incorporated Polyvinyl Alcohol Foam Embolization Particles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Cleared on Dec 23, 2008 as substantially equivalent to K030966 (Boston Scientific Corp, 2003) and 2 other predicates after a 186-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Dec 23, 2008
- Review
- 186 days
- Class
- Class II
- Product code
- NAJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K961923 (1996). 12 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 5 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 4 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 3 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 2 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 1 generation backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- This deviceK081768 Cook Incorporated Polyvinyl Alcohol Foam Embolization ParticlesCook Incorporated · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −5 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −4 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −3 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −2 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −1 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| 0 (this device) | K081768 | Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles | Cook Incorporated | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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 NAJ? 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 NAJ device
- #1 K233813 Bearing nsPVA Express™score 8.3 · 7 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030966 | Contour Emboli Pva and Fastracker-325 Infusion CatheterSummary page 2…orated's Polyvinyl Alcohol Foam Embolization Particles are also substantially equivalent in terms of materials and use to the Contour TM Emboli PVA cleared for market in K030966, ContourTM SE Microspheres cleared for market in K034068, and in terms of use to the Embosphere Microspheres, cleared for market… | 2003 |
| * | K034068 | Contour SE MicrospheresSummary page 2…e also substantially equivalent in terms of materials and use to the Contour TM Emboli PVA cleared for market in K030966, ContourTM SE Microspheres cleared for market in K034068, and in terms of use to the Embosphere Microspheres, cleared for market in K021397. 4. Device Description: Cook Incorporated P… | 2004 |
| * | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationSummary page 2…oli PVA cleared for market in K030966, ContourTM SE Microspheres cleared for market in K034068, and in terms of use to the Embosphere Microspheres, cleared for market in K021397. 4. Device Description: Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles are small, flexible, particles made of… | 2002 |
| * | — | Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles marketed prior to 1976 Named without a submission number |
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 12 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 5 other devices also cite its predicate K030966.
How does its category compare?
All NAJ devicesNAJ Agents, Embolic, For Treatment Of Uterine Fibroids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NAJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NAJ
Too few NAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NAJ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAJ
3in 2025
MAUDE reports naming product code NAJ, 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 | 0 | — | 0 | 46 |
| 2008 | 1 | — | 0 | 23 |
| 2009 | 0 | — | 1 | 11 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for embolization
of the blood supply to symptomatic uterine fibroids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081768: Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081768
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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