510(k) Report

510(k) · Cleared

Cleared

Pva Foam Embolization Particles

K001678510(k) TraditionalCleared Jan 25, 2001238-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

Surgica Corp. · HCG Device, Neurovascular Embolization

Cleared on Jan 25, 2001 after a 238-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Jan 25, 2001
Review
238 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
0

6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2006: 2 descendants cleared2002: 1 descendant cleared2004: 1 descendant cleared200020052010201520202025
  1. This deviceK001678 Pva Foam Embolization ParticlesSurgica Corp. · 2001
  2. Descendant · cites it directly · 4 of its ownK032619 Microstat Pva Foam Embolization ParticlesSurgica Corp. · 2004
  3. Descendant · cites it directly · 4 of its ownK020033 Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002
  4. Descendant · cites it directly · 3 of its ownK053548 Modified Pva-Plus Foam Embolization Particles and Maxistat and…Protein Polymer Technologies, Inc. · 2006
  5. Descendant · 2 generations on · 1 of its ownK061790 Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization ParticlesProtein Polymer Technologies, Inc. · 2006
  6. Descendant · cites it directly · 0 of its ownK073544 Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience…Rj Medical, Inc. · 2008

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12006: 22008: 2
2002high 2 (2006) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K032619Microstat Pva Foam Embolization ParticlesSurgica Corp. · 2004 · cites it directly4descendants
  • K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002 · cites it directly4descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001678Pva Foam Embolization ParticlesSurgica Corp.2001—
+1K032619Microstat Pva Foam Embolization ParticlesSurgica Corp.2004—
+1K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp.2002—
+1K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva…Protein Polymer Technologies, Inc.2006—
+2K061790Pva 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200620
200820
FIG. 1 — Lineage of K001678, 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032619Microstat Pva Foam Embolization ParticlesSurgica Corp.20044
K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp.20024
K053548Modified Pva-Plus Foam Embolization Particles and Maxistat and Microstat Pva Foam…Protein Polymer Technologies, Inc.20063
K073544Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Foam…Rj Medical, Inc.20080
K073419Pva Plus Vial Pva Foam Embolization Particles, Pva Plus Convenience Kit Pva Embolization…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?

  • Of its descendants, K032619 (Surgica Corp., 2004) has gone furthest, with 4 descendants of its own.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Surgica Corp.

3 FDA decisions under this applicant name. See the company

  • K032619Microstat Pva Foam Embolization ParticlesSurgica Corp. · 2004
  • K020033Maxistat Pva Foam Embolization ParticlesSurgica Corp. · 2002

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/K001678 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001678: 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/K001678

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026