510(k) · Cleared
ClearedPva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam Embolization Particles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rj Medical, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Mar 5, 2008 as substantially equivalent to K001678 (Surgica Corp., 2001) and 4 other predicates after a 78-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Mar 5, 2008
- Review
- 78 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K961923 (1996). 17 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 6 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 5 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 4 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 3 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 2 generations backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- 1 generation backK061790 Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006
- This deviceK073544 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −6 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −5 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −4 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −3 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −2 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| −1 | K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles | Protein Polymer Technologies, Inc. | 2006 | — |
| 0 (this device) | K073544 | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 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 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 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 2…stem for the embolization of AVMs and neoplastic lesions. 5.6 Comparison to Predicate Devices The subject devices are identical to both the Surgica product (K001678) PVA Foam Embolization Particles and the Corporation Protein Polymer Technologies, Inc. product (K053548 & K061790)… | 2001 |
| * | K020033 | Maxistat Pva Foam Embolization ParticlesSummary page 1…owing predicate devices: Y PVA PLUS" Foam Embolization Particles (Surgica Corp.; KOO 1678) Y MaxiStat" PVA Foam Embolization Particles (Surgica Corn.; K020033) Y MicroStat" PVA Foam Embolization Particles (Surgica Corp.; K032619) -15… | 2002 |
| * | K032619 | Microstat Pva Foam Embolization ParticlesSummary page 1…s (Surgica Corp.; KOO 1678) Y MaxiStat" PVA Foam Embolization Particles (Surgica Corn.; K020033) Y MicroStat" PVA Foam Embolization Particles (Surgica Corp.; K032619) -15 - ~JMedical, Inc.] * Modified PVA PLUS TM , Modifi… | 2004 |
| * | K053548 | Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam…Summary page 2….] * Modified PVA PLUS TM , Modified MaxiStatTM, and Modified MicroStat TM PVA Foam Embolization Particles (Protein Polymer Technologies, Inc.; K053548) * Modified PVA PLUSTM, Modified MaxiStatTM, and Modified MicroStatTM PVA Foam Embolization Particles (Protein P… | 2006 |
| * | K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesSummary page 2…3548) * Modified PVA PLUSTM, Modified MaxiStatTM, and Modified MicroStatTM PVA Foam Embolization Particles (Protein Polymer Technologies, Inc.; K061790) 5.4 Device Description The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA)… | 2006 |
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 6 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 4 other devices also cite its predicate K001678.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
PVA particles are indicated for vascular occlusion of blood vessels within the neurovascular and peripheral vascular system. They are intended 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.
https://510kreport.com/device/K073544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073544: Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit 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/K073544
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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