510(k) Report

510(k) · Cleared

Cleared

Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization Particles

K073419510(k) TraditionalCleared Feb 14, 200871-day reviewClass II21 CFR 882.5950

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

Rj Medical, Inc. · HCG Device, Neurovascular Embolization

Cleared on Feb 14, 2008 as substantially equivalent to K001678 (Surgica Corp., 2001) and 3 other predicates after a 71-day review. Its family tree reaches back 3 generations to 2001.

Decided
Feb 14, 2008
Review
71 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K001678 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestorK001678 · Pva Foam Embolization Particles · Surgica Corp. · 2001K020033 · Maxistat Pva Foam Embolization Particles · Surgica Corp. · 2002K053548 · Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles · Protein Polymer Technologies, Inc. · 2006200020022004200620082010
Other ancestors, by generation 1 generation back: 1 other ancestor K053548 · Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization Particles · Protein Polymer Technologies, Inc. · 2006K020033 · Maxistat Pva Foam Embolization Particles · Surgica Corp. · 2002K001678 · Pva Foam Embolization Particles · Surgica Corp. · 20010
  1. Root · 3 generations backK001678 Pva Foam Embolization ParticlesSurgica Corp. · 2001
  2. 2 generations backK020033 Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002
  3. 1 generation backK053548 Modified Pva-Plus Foam Embolization Particles and Maxistat and…Protein Polymer Technologies, Inc. · 2006
  4. This deviceK073419 Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience…Rj Medical, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001678Pva Foam Embolization ParticlesSurgica Corp.2001—
−2K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp.2002—
−1K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva…Protein Polymer Technologies, Inc.2006—
0 (this device)K073419Pva 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
200410
FIG. 1 — Lineage of K073419, 2001–2008Source: 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 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. #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 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
*K001678Pva Foam Embolization Particles
Summary page 1
…vices The subject devices are substantially equivalent to the following predicate devices: Y PVA PLUS" Foam Embolization Particles (Surgica Corp.; K001678) Y MaxiStat" PVA Foam Embolization Particles (Surgica Corp.; K020033) Y MicroStat" PVA Foam Embolization Particles…
Surgica Corp.2001—
*K020033Maxistat Pva Foam Embolization Particles
Summary page 1
…ing predicate devices: Y PVA PLUS" Foam Embolization Particles (Surgica Corp.; K001678) Y MaxiStat" PVA Foam Embolization Particles (Surgica Corp.; K020033) Y MicroStat" PVA Foam Embolization Particles (Surgica Corp.; K032619) -15…
Surgica Corp.2002—
*K032619Microstat Pva Foam Embolization Particles
Summary page 1
…(Surgica Corp.; K001678) Y MaxiStat" PVA Foam Embolization Particles (Surgica Corp.; K020033) Y MicroStat" PVA Foam Embolization Particles (Surgica Corp.; K032619) -15 -…
Surgica Corp.2004—
*K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam…
Summary page 2
…Modified PVA PLUSTM, Modified MaxiStatTM, and Modified MicroStatTM PVA Foam Embolization Particles (Protein Polymer Technologies, Inc.; K053548) 5.4 Device Description The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol…
Protein Polymer Technologies, Inc.2006—

Also cleared against K001678: 4 other devices →

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 7 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
  • None of the 4 ancestors has a recall.
  • 4 other devices also cite its predicate K001678.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HCG

3in 2025

2007: 82008: 92009: 72010: 82011: 92012: 72013: 72014: 52015: 52016: 72017: 52018: 42019: 12020: 22021: 52022: 32023: 22024: 42025: 32026 (partial year): 4
2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007: 50 days median2008: 71 days median2009: 48 days median2010: 72 days median2011: 78 days median2012: 30 days median2013: 67 days median2014: 66 days median2015: 60 days median2016: 37 days median2017: 97 days median2018: 173 days median2021: 103 days median2022: 114 days median2024: 49 days median2025: 107 days median2026 (partial year): 30 days median
2007high 173 (2018) · low 30 (2012)2026

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

Recalls per year · HCG

1in 2025

2007: 12008: 32010: 22011: 12013: 22014: 42022: 22024: 12025: 1, 1 Class I2026 (partial year): 1
2007high 4 (2014) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HCG

537in 2025

2007: 3262008: 7302009: 8212010: 8512011: 8942012: 1,1462013: 1,1032014: 1,7292015: 1,5982016: 1,9912017: 2,4942018: 2,0582019: 1,7632020: 1,7542021: 2,2682022: 6632023: 5682024: 5522025: 537
2007high 2,494 (2017) · low 326 (2007)2025

MAUDE reports naming product code HCG, 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
20078501326
20089713730
20097480821
20108722851
20119781894
201273001,146
201376721,103
201456641,729
201556001,598
201673701,991
201759702,494
2018417302,058
20191—01,763
20202—01,754
2021510302,268
202231142663
20232—0568
20244491552
202531071 (1)537
20264301—

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 (AVM's) and neoplastic lesions when presurgical devascularization is desirable.

Indications for use as stated in the FDA summary.

Also cleared against K001678

4 other devices cite the same predicate.

  • K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization ParticlesRj Medical, Inc. · 2008
  • K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006
  • K032619Microstat Pva Foam Embolization ParticlesSurgica Corp. · 2004
  • K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002

More from Rj Medical, Inc.

2 FDA decisions under this applicant name. See the company

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

Recent decisions in HCG

The HCG category page

  • K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356)…Cerenovus, Inc. · 2026
  • K261772Target Xtra Detachable CoilStryker Neurovscular · 2026
  • K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
  • K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC · 2026
  • K252694Target Detachable CoilStryker Neurovascular · 2025

https://510kreport.com/device/K073419 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073419: Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva 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/K073419

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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