510(k) Report

510(k) · Cleared

Cleared

Concentric Embolic Pearls

K050470510(k) TraditionalCleared May 6, 200572-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

Concentric Medical, Inc. · KRD Device, Vascular, For Promoting Embolization

Cleared on May 6, 2005 as substantially equivalent to K991549 (Biosphere Medical, 2000) and 3 other predicates after a 72-day review. Its family tree reaches back 3 generations to 1996.

Decided
May 6, 2005
Review
72 days
Class
Class II
Product code
KRD
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K961923 (1996). 8 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1987: 1 other ancestorK961923 · Berenstein Coil · Target Therapeutics · 1996K964112 · Berenstein Coil · Target Therapeutics · 1997K991549 · Embosphere Microspheres · Biosphere Medical · 200019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors K991549 · Embosphere Microspheres · Biosphere Medical · 2000K964112 · Berenstein Coil · Target Therapeutics · 1997K961923 · Berenstein Coil · Target Therapeutics · 19960
  1. Root · 3 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
  2. 2 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
  3. 1 generation backK991549 Embosphere MicrospheresBiosphere Medical · 2000
  4. This deviceK050470 Concentric Embolic PearlsConcentric Medical, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961923Berenstein CoilTarget Therapeutics1996—
−2K964112Berenstein CoilTarget Therapeutics1997—
−1K991549Embosphere MicrospheresBiosphere Medical2000—
0 (this device)K050470Concentric Embolic PearlsConcentric Medical, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
199510
199710
200110
FIG. 1 — Lineage of K050470, 1996–2005Source: 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
*K991549Embosphere Microspheres
Summary page 1
…earls are intended for use in the embolization of hypervascularized tumors in the peripheral vasculature. Predicate Devices EMBOSPHERE® Microspheres K991549 Manufactured by Biosphere Medical, Inc. EmboGoIdTM Microspheres K010026 Manufactured by Biosphere Medical,…
Biosphere Medical2000—
*K010026Embogold Microsphere
Summary page 1
…asculature. Predicate Devices EMBOSPHERE® Microspheres K991549 Manufactured by Biosphere Medical, Inc. EmboGoIdTM Microspheres K010026 Manufactured by Biosphere Medical, Inc. TruFiIITM PVA Particles K951314, K965174 Manufactured by Cordis Endovas…
Biosphere Medical, Inc.2001—
*K951314Truefill Pva Particles
Summary page 1
…ctured by Biosphere Medical, Inc. EmboGoIdTM Microspheres K010026 Manufactured by Biosphere Medical, Inc. TruFiIITM PVA Particles K951314, K965174 Manufactured by Cordis Endovascular Systems Device Description The Concentric Embolic Pearls are non-resorbable, hydrog…
Cordis Neurovascular, Inc.1995—
*K965174Trufill Pva Particles
Summary page 1
…Biosphere Medical, Inc. EmboGoIdTM Microspheres K010026 Manufactured by Biosphere Medical, Inc. TruFiIITM PVA Particles K951314, K965174 Manufactured by Cordis Endovascular Systems Device Description The Concentric Embolic Pearls are non-resorbable, hydrogel-based…
Cordis Neurovascular, Inc.1997—

Also cleared against K991549: 6 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 9 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
  • None of the 8 ancestors has a recall.
  • 6 other devices also cite its predicate K991549.

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?

The Concentric Embolic Pearls are indicated for use in the embolization of hypervascularized tumors in the peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K991549

6 other devices cite the same predicate.

  • K150870HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc. · 20151 recall
  • K113266Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
  • K093813Occlusin 500 Artificial Embolization DeviceImbiotechnologies · 2010
  • K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
  • K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 20031 recall
  • K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc. · 2002

More from Concentric Medical, Inc.

45 FDA decisions under this applicant name. See the company

  • K173352Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)Concentric Medical, Inc. · 20181 recall
  • DEN150049Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo…Concentric Medical, Inc. · 2016
  • K150616Trevo XP ProVue Retriever (4x30mm)Concentric Medical, Inc. · 2015
  • K143077Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc. · 20153 recalls
  • K133177Modified HD Guide CatheterConcentric Medical, Inc. · 20143 recalls

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/K050470 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050470: Concentric Embolic Pearls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050470

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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