Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Icrco, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
309 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132499 | ICRCO CLARITY VIEWER | Icrco, Inc. | 2014-01-21 | 165 | 0 |
| K122510 | ICRCO 3600M | Icrco, Inc. | 2013-04-26 | 252 | 0 |
| K120753 | CLARISCT | Icrco, Inc. | 2012-07-26 | 135 | 0 |
| K113449 | FUSION FLAT PANEL | Icrco, Inc. | 2012-06-14 | 206 | 0 |
| K082450 | IDR | Icrco, Inc. | 2009-06-30 | 309 | 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