Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Confirma, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
244 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092954 | CADSTREAM VERSION 5 | Confirma, Inc. | 2009-11-06 | 42 | 0 |
| K081556 | CADSTREAM, VERSION 5.0 | Confirma, Inc. | 2009-02-02 | 244 | 0 |
| K071534 | CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS | Confirma, Inc. | 2007-07-09 | 34 | 0 |
| K060547 | ACCESS BREAST COIL 4/SMS | Confirma, Inc. | 2006-03-29 | 28 | 0 |
| K052045 | ACCESS BREAST COIL | Confirma, Inc. | 2005-08-24 | 27 | 0 |
| K043216 | CADSTREAM VERSION 4.0 | Confirma, Inc. | 2005-01-06 | 45 | 0 |
| K041020 | CADSTREAM VERSION 3.1 | Confirma, Inc. | 2004-07-07 | 78 | 0 |
| K031779 | CADSTREAM | Confirma, Inc. | 2003-08-06 | 57 | 0 |
| K013574 | ACCENT | Confirma, Inc. | 2002-01-15 | 78 | 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