Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
C-Rad Positioning AB — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
203 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200435 | Catalyst+, Catalyst+ HD | C-Rad Positioning AB | 2020-05-07 | 73 | 2 |
| K200600 | Sentinel | C-Rad Positioning AB | 2020-04-20 | 42 | 0 |
| K120668 | SENTINEL | C-Rad Positioning AB | 2012-07-30 | 147 | 0 |
| K113276 | CATALYST | C-Rad Positioning AB | 2012-02-27 | 112 | 0 |
| K082582 | SENTINEL, MODEL SP-001 | C-Rad Positioning AB | 2009-03-30 | 203 | 0 |
| K063839 | POSITIONER | C-Rad Positioning AB | 2007-02-08 | 44 | 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