510(k) Report

510(k) · Cleared

Cleared

Concentric Micro Catheter, Models 90001 to 90008

K003086510(k) TraditionalCleared May 16, 2001225-day reviewClass II21 CFR 870.1200

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

Concentric Medical, Inc. · DQO Catheter, Intravascular, Diagnostic

Cleared on May 16, 2001 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 131 devices in its family, counting itself, have a Class I recall. 130 later devices descend from it.

Decided
May 16, 2001
Review
225 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

130 later devices descend from it, 2 citing it directly. 6 of the 131 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2007: 1 descendant cleared2009: 1 descendant cleared2010: 2 descendants cleared2014: 1 descendant cleared2011: 2 descendants cleared2012: 3 descendants cleared2015: 4 descendants cleared2023: 11 descendants cleared, 2 with a Class I recall22024: 12 descendants cleared2019: 8 descendants cleared, 1 with a Class I recall12026: 19 descendants cleared2016: 7 descendants cleared2021: 7 descendants cleared2013: 1 descendant cleared2020: 10 descendants cleared, 2 with a Class I recall22025: 19 descendants cleared2022: 6 descendants cleared2018: 13 descendants cleared2017: 3 descendants cleared, 1 with a Class I recall1200020052010201520202025
  1. This deviceK003086 Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc. · 2001
  2. Descendant · cites it directly · 120 of its ownK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
  3. Descendant · 2 generations on · 118 of its ownK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
  4. Descendant · 2 generations on · 116 of its ownK113163 Penumbra System MaxPenumbra, Inc. · 2011
  5. Descendant · 2 generations on · 61 of its ownK133317 Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014
  6. Descendant · 2 generations on · 60 of its ownK142458 Penumbra System ACEPenumbra, Inc. · 2015

Showing 5 of 130 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 22011: 22012: 32013: 12014: 12015: 42016: 72017: 32018: 132019: 82020: 102021: 72022: 62023: 112024: 122025: 192026: 19
2007high 19 (2025) · low 0 (2008)2026

Class I recalls in this family

  • K162901 Penumbra 3D Revascularization Device5 generations on · 2017
  • K223530 Route 92 Medical Full Length 070 Reperfusion…5 generations on · 2023
  • K190010 Penumbra System Reperfusion Catheter JET 77 generations on · 2019
  • K191946 Penumbra System Penumbra JET 7X8 generations on · 2020

Most influential descendants

Showing 5 of 130 · See all
  • K072718Penumbra SystemPenumbra, Inc. · 2007 · cites it directly120descendants
  • K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054Penumbra, Inc. · 2010 · 2 generations on118descendants
  • K113163Penumbra System MaxPenumbra, Inc. · 2011 · 2 generations on116descendants
  • K133317Penumbra System / Penumbra System MaxPenumbra, Inc. · 2014 · 2 generations on61descendants
  • K142458Penumbra System ACEPenumbra, Inc. · 2015 · 2 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003086Concentric Micro Catheter, Models 90001 to 90008Concentric Medical, Inc.2001—
+1K072718Penumbra SystemPenumbra, Inc.20071
+2K100769Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032…Penumbra, Inc.2010—
+2K113163Penumbra System MaxPenumbra, Inc.2011—
+2K133317Penumbra System / Penumbra System MaxPenumbra, Inc.2014—
+2K142458Penumbra System ACEPenumbra, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201020
201120
201230
201310
201410
201540
201670
201731
2018130
201981
2020102
202170
202260
2023112
2024120
2025190
2026190
FIG. 1 — Lineage of K003086, 2001–2026Source: 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.

6 devices in this family have a Class I recall. 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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?

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

What descends from it? (130)

See all 130

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

NumberDeviceApplicantDecidedDescendants
K072718Penumbra SystemPenumbra, Inc.2007120
K091961Modified Concentric Microcatheter, Model 90047Concentric Medical, Inc.20098

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
  • K223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
  • K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
  • K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)Penumbra, Inc. · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
  • K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · 9 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

  • Of its descendants, K072718 (Penumbra, Inc., 2007) has gone furthest, with 120 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

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 DQO

The DQO category page

  • K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF…Bioptimal International Pte., Ltd. · 2026
  • K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular · 2026
  • K250751DualView CatheterTerumo Corporation · 2025
  • K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC · 20251 recall

https://510kreport.com/device/K003086 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003086: Concentric Micro Catheter, Models 90001 to 90008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003086

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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