510(k) · Cleared
ClearedMaxistat Pva Foam Embolization Particles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgica Corp. · HCG Device, Neurovascular Embolization
Cleared on May 31, 2002 as substantially equivalent to K001678 (Surgica Corp., 2001) after a 147-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- May 31, 2002
- Review
- 147 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001678 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001678 Pva Foam Embolization ParticlesSurgica Corp. · 2001
- This deviceK020033 Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002
- Descendant · cites it directly · 3 of its ownK053548 Modified Pva-Plus Foam Embolization Particles and Maxistat and…Protein Polymer Technologies, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK061790 Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK073544 Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience…Rj Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK073419 Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience…Rj Medical, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam…Protein Polymer Technologies, Inc. · 2006 · cites it directly3descendants
- K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006 · 2 generations on1descendant
- K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc. · 2008 · cites it directly0descendants
- K073419Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization…Rj Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001678 | Pva Foam Embolization Particles | Surgica Corp. | 2001 | — |
| 0 (this device) | K020033 | Maxistat Pva Foam Embolization Particles | Surgica Corp. | 2002 | — |
| +1 | K053548 | Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva… | Protein Polymer Technologies, Inc. | 2006 | — |
| +2 | K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles | Protein Polymer Technologies, Inc. | 2006 | — |
| +1 | K073544 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva… | Rj Medical, Inc. | 2008 | — |
| +1 | K073419 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva… | Rj Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 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 HCG? 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? (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 |
|---|---|---|---|
| * | K001678 | Pva Foam Embolization ParticlesSummary page 1…neoplastic lesions when presurgical devascularization is desirable. Predicate Devices: The EMB™ PVA Foam Embolization Particle devices marketed by Surgica Corporation (K001678) represent is the predicate device for the Surgica Corporation MaxiStat™ Polyvinyl Foam Embolizaion Particles. Clinical Tests: N… | 2001 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053548 | Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam… | 2006 | 3 |
| K073544 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam… | 2008 | 0 |
| K073419 | Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization… | 2008 | 0 |
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?
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?
The Surgica Corporation MaxiStat™ PVA Foam Embolization Particles are intended for the following indication:
PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
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/K020033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020033: Maxistat Pva 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/K020033
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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