Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Analogic Corporation — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
47 daysmedian FDA review time
271 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201231 | CTxx85 CT Scanner | Analogic Corporation | 2021-02-02 | 271 | 0 |
| K182147 | CTXX85 | Analogic Corporation | 2018-09-07 | 30 | 0 |
| K172058 | CT6485, CT12885 | Analogic Corporation | 2018-02-13 | 222 | 0 |
| K161342 | Sonic Window | Analogic Corporation | 2016-06-15 | 33 | 0 |
| K140126 | SONIC WINDOW | Analogic Corporation | 2014-03-04 | 47 | 0 |
| K070829 | SYNEPIX 4600 DETECTOR | Analogic Corporation | 2007-05-09 | 44 | 0 |
| K051903 | FETALGARD LITE-NIBP, MODEL FGL-NIBP | Analogic Corporation | 2005-12-27 | 167 | 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