510(k) · Cleared
ClearedModified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Protein Polymer Technologies, Inc. · HCG Device, Neurovascular Embolization
Cleared on Jan 30, 2006 as substantially equivalent to K001678 (Surgica Corp., 2001) and 2 other predicates after a 41-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Jan 30, 2006
- Review
- 41 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001678 (2001). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001678 Pva Foam Embolization ParticlesSurgica Corp. · 2001
- 1 generation backK020033 Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002
- This deviceK053548 Modified Pva-Plus Foam Embolization Particles and Maxistat and…Protein Polymer Technologies, Inc. · 2006
- Descendant · cites it directly · 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 3 of 3 · See all- K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| −2 | K001678 | Pva Foam Embolization Particles | Surgica Corp. | 2001 | — |
| −1 | K020033 | Maxistat Pva Foam Embolization Particles | Surgica Corp. | 2002 | — |
| 0 (this device) | K053548 | Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva… | Protein Polymer Technologies, Inc. | 2006 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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? (3)
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…The subject devices are su~bstantially equnival ent to the following2 pied icate devices: *Pva-Pli/A "I FoamiFinbolization Particles (Stirgica Corp).: K00 1678) * MutiSiat "I Pva Foam Em bol ization Particles (Surgi ca Corp.: K02003 3) *Miu roStat "' Pva Foam Em bol iz… | 2001 |
| * | K020033 | Maxistat Pva Foam Embolization ParticlesSummary page 1…cate devices: *Pva-Pli/A "I FoamiFinbolization Particles (Stirgica Corp).: K00 1678) * MutiSiat "I Pva Foam Em bol ization Particles (Surgi ca Corp.: K02003 3) *Miu roStat "' Pva Foam Em bol izati on Particles (Surgioca Corp.; K0326 19) 5.4 Device Description The s… | 2002 |
| * | K032619 | Microstat Pva Foam Embolization ParticlesSummary page 1…0 1678) * MutiSiat "I Pva Foam Em bol ization Particles (Surgi ca Corp.: K02003 3) *Miu roStat "' Pva Foam Em bol izati on Particles (Surgioca Corp.; K0326 19) 5.4 Device Description The subject devices are particles of nonabsorbable synthetic polyvinyl alcohlol (Pva)… | 2004 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles | 2006 | 1 |
| 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K061790 (Protein Polymer Technologies, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K001678.
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?
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/K053548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053548: Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053548
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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