510(k) Report

510(k) · Cleared

Cleared

Modified Concentric Retriever, Model 90039

K051838510(k) SpecialCleared Sep 1, 200556-day reviewClass II21 CFR 870.1250

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

Concentric Medical, Inc. · DQY Catheter, Percutaneous

Cleared on Sep 1, 2005 as substantially equivalent to K040745 (Concentric Medical, Inc., 2004) after a 56-day review. Its family tree reaches back 3 generations to 2001.

Decided
Sep 1, 2005
Review
56 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K003410 (2001). No later device cites it as a predicate yet.

K003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalledK030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK040745 · Modified Concentric Retriever, Model 90038 · Concentric Medical, Inc. · 20042000200220042006
K040745 · Modified Concentric Retriever, Model 90038 · Concentric Medical, Inc. · 2004K030476 · Modified Concentric Retriever, Model 90037 · Concentric Medical, Inc. · 2003 · recalledK003410 · Concentric Retriever, Model 90030 · Concentric Medical, Inc. · 2001 · recalled0
  1. Root · 3 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
  2. 2 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
  3. 1 generation backK040745 Modified Concentric Retriever, Model 90038Concentric Medical, Inc. · 2004
  4. This deviceK051838 Modified Concentric Retriever, Model 90039Concentric Medical, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K003410Concentric Retriever, Model 90030Concentric Medical, Inc.20011
−2K030476Modified Concentric Retriever, Model 90037Concentric Medical, Inc.20032
−1K040745Modified Concentric Retriever, Model 90038Concentric Medical, Inc.2004—
0 (this device)K051838Modified Concentric Retriever, Model 90039Concentric Medical, Inc.2005—
FIG. 1 — Lineage of K051838, 2001–2005Source: 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 DQY? 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (1)

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
*K040745Modified Concentric Retriever, Model 90038
Summary page 1
…ring interventional radiological procedures in the neuro, peripheral and coronary vascular systems. Predicate Device Concentric Retriever LX K040745 Manufactured by Concentric Medical, Inc. Device Description The Modified Concentric Retriever consists of a flexible, tapered…
Concentric Medical, Inc.2004—

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 4 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
  • 2 of the 3 ancestors have a recall of any class.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

What is it indicated for?

The Modified Concentric Retriever is intended to remove foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

Indications for use as stated in the FDA summary.

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 DQY

The DQY category page

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https://510kreport.com/device/K051838 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051838: Modified Concentric Retriever, Model 90039.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051838

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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