510(k) Report

510(k) · Cleared

Cleared

Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles

K061790510(k) TraditionalCleared Sep 19, 200685-day reviewClass II21 CFR 870.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Protein Polymer Technologies, Inc. · KRD Device, Vascular, For Promoting Embolization

Cleared on Sep 19, 2006 as substantially equivalent to K053548 (Protein Polymer Technologies, Inc., 2006) and 3 other predicates after an 85-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.

Decided
Sep 19, 2006
Review
85 days
Class
Class II
Product code
KRD
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K961923 (1996). 16 ancestors in all, the oldest K871047 (1987). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2003: 2 other ancestors2002: 2 other ancestors2001: 2 other ancestors1994: 1 other ancestor1987: 1 other ancestor2008: 1 descendant clearedK961923 · Berenstein Coil · Target Therapeutics · 1996K964112 · Berenstein Coil · Target Therapeutics · 1997K991549 · Embosphere Microspheres · Biosphere Medical · 2000K021397 · Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization · Biosphere Medical, Inc. · 2002K030966 · Contour Emboli Pva and Fastracker-325 Infusion Catheter · Boston Scientific Corp · 2003 · recalledK034068 · Contour SE Microspheres · Boston Scientific Corp · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 9 other ancestors 1 generation forward: 1 descendant K034068 · Contour SE Microspheres · Boston Scientific Corp · 2004K030966 · Contour Emboli Pva and Fastracker-325 Infusion Catheter · Boston Scientific Corp · 2003 · recalledK021397 · Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization · Biosphere Medical, Inc. · 2002K991549 · Embosphere Microspheres · Biosphere Medical · 2000K964112 · Berenstein Coil · Target Therapeutics · 1997K961923 · Berenstein Coil · Target Therapeutics · 1996−50
  1. Root · 6 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
  2. 5 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
  3. 4 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
  4. 3 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
  5. 2 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
  6. 1 generation backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
  7. This deviceK061790 Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006
  8. Descendant · cites it directly · 0 of its ownK073544 Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience…Rj Medical, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K961923Berenstein CoilTarget Therapeutics1996—
−5K964112Berenstein CoilTarget Therapeutics1997—
−4K991549Embosphere MicrospheresBiosphere Medical2000—
−3K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid…Biosphere Medical, Inc.2002—
−2K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp20031
−1K034068Contour SE MicrospheresBoston Scientific Corp2004—
0 (this device)K061790Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc.2006—
+1K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva…Rj Medical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
200120
200220
200320
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K061790, 1996–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KRD? 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. #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam…
Summary page 1
…Predicate Devices The subject devices are substantially equivalent to the following predicate devices: * PVA PIusTM Foam Embolization Particles (PPTI; K053548) • MaxiSratTM l PVA Foam Embolization Particles (PPTI; K053548) • MicroStarT M PVA Foam Embolization Particle…
Protein Polymer Technologies, Inc.2006—
*K034068Contour SE Microspheres
Summary page 1
…mbolization Particles (PPTI; K053548) • MicroStarT M PVA Foam Embolization Particles (PPTI; K053548) * Contour SET M Microspheres (Boston Scientific; K034068) ° Contour®Emboli PVA (Boston Scientific; K030966) * Embosphere®Microspheres (Biosphere Medical; K021397) 5.…
Boston Scientific Corp2004—
*K030966Contour Emboli Pva and Fastracker-325 Infusion Catheter
Summary page 1
…M PVA Foam Embolization Particles (PPTI; K053548) * Contour SET M Microspheres (Boston Scientific; K034068) ° Contour®Emboli PVA (Boston Scientific; K030966) * Embosphere®Microspheres (Biosphere Medical; K021397) 5.4 Device Description The subject devices are part…
Boston Scientific Corp20031
*K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization
Summary page 1
…ntour SET M Microspheres (Boston Scientific; K034068) ° Contour®Emboli PVA (Boston Scientific; K030966) * Embosphere®Microspheres (Biosphere Medical; K021397) 5.4 Device Description The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) f…
Biosphere Medical, Inc.2002—

Also cleared against K053548: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080

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 10 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
  • 1 of the 16 ancestors has a recall of any class.
  • Of its descendants, K073544 (Rj Medical, Inc., 2008) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K053548.

How does its category compare?

All KRD devices

KRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRD

9in 2025

2007: 22008: 52009: 42010: 32011: 52012: 82013: 112014: 72015: 112016: 42017: 42018: 42019: 62020: 42021: 32022: 82023: 22024: 62025: 92026 (partial year): 7
2007high 11 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRD

60in 2025

2008: 84 days median2009: 27 days median2010: 150 days median2011: 36 days median2012: 30 days median2013: 33 days median2014: 134 days median2015: 130 days median2016: 164 days median2017: 89 days median2018: 62 days median2019: 178 days median2020: 137 days median2021: 134 days median2022: 175 days median2024: 70 days median2025: 60 days median2026 (partial year): 70 days median
2007high 178 (2019) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KRD

1in 2024

2010: 12013: 12023: 12024: 12026 (partial year): 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRD

1,572in 2025

2007: 212008: 142009: 402010: 612011: 1022012: 1372013: 2442014: 1592015: 3372016: 4372017: 7362018: 1,0662019: 1,1852020: 1,1672021: 1,4442022: 1,4982023: 1,3712024: 1,5352025: 1,572
2007high 1,572 (2025) · low 14 (2008)2025

MAUDE reports naming product code KRD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—021
2008584014
2009427040
20103150161
20115360102
20128300137
201311331244
201471340159
2015111300337
201641640437
20174890736
201846201,066
2019617801,185
2020413701,167
2021313401,444
2022817501,498
20232—11,371
202467011,535
202596001,572
20267701—

What is it indicated for?

PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

Indications for use as stated in the FDA summary.

Also cleared against K053548

2 other devices cite the same predicate.

  • K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization ParticlesRj Medical, Inc. · 2008
  • K073419Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization ParticlesRj Medical, Inc. · 2008

More from Protein Polymer Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006

Recent decisions in KRD

The KRD category page

  • K262798LOBO Vascular Occlusion SystemOkami Medical, Inc. · 2026
  • K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd. · 2026
  • K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026
  • K261866Concerto Versa™ Detachable CoilMedtronic, Inc. · 2026
  • K260635HARBOR Occlusion DeviceNuvascular, Inc. · 2026

https://510kreport.com/device/K061790 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061790: Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061790

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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