Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Concentric Medical, Inc. · Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
225 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trev | Concentric Medical, Inc. | 2018-02-15 | 113 | 1 |
| DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4 | Concentric Medical, Inc. | 2016-09-02 | 312 | 0 |
| K150616 | Trevo XP ProVue Retriever (4x30mm) | Concentric Medical, Inc. | 2015-06-12 | 94 | 0 |
| K143077 | Trevo XP ProVue Retriever (6X25mm) | Concentric Medical, Inc. | 2015-04-06 | 161 | 3 |
| K133177 | MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2014-02-25 | 131 | 3 |
| K133464 | MODIFIED TREVO PROVUE RETRIEVER | Concentric Medical, Inc. | 2014-01-17 | 66 | 1 |
| K132641 | MODIFIED TREVO PROVUE RETRIEVER | Concentric Medical, Inc. | 2014-01-13 | 140 | 3 |
| K131437 | MODIFIED CONCENTRIC MICROCATHETER | Concentric Medical, Inc. | 2013-10-11 | 144 | 2 |
| K131492 | MODIFIED FLOWGATE BALLOON GUIDE CATHETER | Concentric Medical, Inc. | 2013-10-03 | 133 | 0 |
| K122581 | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 | Concentric Medical, Inc. | 2012-11-21 | 90 | 1 |
| K122478 | MODIFIED TREVO RETRIEVER | Concentric Medical, Inc. | 2012-10-31 | 78 | 0 |
| K120961 | TREVO RETRIEVER | Concentric Medical, Inc. | 2012-08-03 | 126 | 1 |
| K112404 | CONCENTRIC BALLOON GUIDE CATHETER | Concentric Medical, Inc. | 2012-03-15 | 206 | 0 |
| K113260 | MODIFIED CONCENTIRC MICROCATHETER | Concentric Medical, Inc. | 2012-03-09 | 126 | 4 |
| K111619 | MODIFIED CONCENTRIC MICROCATHETER | Concentric Medical, Inc. | 2011-07-06 | 26 | 0 |
| K110483 | MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2011-04-04 | 45 | 1 |
| K093610 | MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, | Concentric Medical, Inc. | 2011-02-17 | 454 | 0 |
| K102657 | CONCENTRIC BALLOON GUIDE CATHETER | Concentric Medical, Inc. | 2010-11-17 | 63 | 0 |
| K092298 | MODIFICATION TO MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2009-11-05 | 99 | 0 |
| K091703 | HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, | Concentric Medical, Inc. | 2009-10-14 | 126 | 0 |
| K091961 | MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 | Concentric Medical, Inc. | 2009-07-30 | 29 | 0 |
| K090335 | HD GUIDE CATHETER | Concentric Medical, Inc. | 2009-05-06 | 85 | 0 |
| K090085 | MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 9 | Concentric Medical, Inc. | 2009-02-12 | 30 | 0 |
| K082034 | MODIFICATION TO MERCI RETRIEVER | Concentric Medical, Inc. | 2008-08-15 | 29 | 1 |
| K080583 | MODIFIED HD GUIDE CATHETER | Concentric Medical, Inc. | 2008-07-18 | 137 | 0 |
| K081305 | MERCI RETRIEVER | Concentric Medical, Inc. | 2008-06-05 | 28 | 0 |
| K072796 | MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90 | Concentric Medical, Inc. | 2007-12-18 | 78 | 0 |
| K071172 | MODIFIED MERCI RETRIEVER, MODEL 90060 | Concentric Medical, Inc. | 2007-08-22 | 117 | 0 |
| K070521 | MODIFIED MERCY RETRIEVER, MODEL 90070 | Concentric Medical, Inc. | 2007-04-24 | 60 | 0 |
| K063774 | MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 | Concentric Medical, Inc. | 2007-01-24 | 34 | 0 |
| K062046 | MODIFIED MERCI RETRIEVER, MODEL 90050 | Concentric Medical, Inc. | 2007-01-19 | 184 | 0 |
| K061059 | MODIFIED MERCI RETRIEVER, MODEL 90092 | Concentric Medical, Inc. | 2006-05-25 | 38 | 0 |
| K051838 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 | Concentric Medical, Inc. | 2005-09-01 | 56 | 0 |
| K050470 | CONCENTRIC EMBOLIC PEARLS | Concentric Medical, Inc. | 2005-05-06 | 72 | 0 |
| K040745 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 | Concentric Medical, Inc. | 2004-08-11 | 141 | 0 |
| K033736 | MERCI RETRIEVER, MODELS 90065, 90066 | Concentric Medical, Inc. | 2004-08-11 | 257 | 0 |
| K040700 | CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X | Concentric Medical, Inc. | 2004-06-21 | 96 | 0 |
| K030476 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 | Concentric Medical, Inc. | 2003-03-11 | 26 | 2 |
| K021899 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 | Concentric Medical, Inc. | 2002-07-10 | 30 | 1 |
| K010954 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 | Concentric Medical, Inc. | 2001-10-09 | 193 | 0 |
| K003410 | CONCENTRIC RETRIEVER, MODEL 90030 | Concentric Medical, Inc. | 2001-05-22 | 201 | 1 |
| K003084 | CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 | Concentric Medical, Inc. | 2001-05-16 | 225 | 0 |
| K003086 | CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008 | Concentric Medical, Inc. | 2001-05-16 | 225 | 0 |
| K003880 | CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), | Concentric Medical, Inc. | 2001-05-16 | 152 | 0 |
| K003085 | CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 | Concentric Medical, Inc. | 2001-03-07 | 155 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda