Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
St. Jude Medical Systems AB · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
262 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140466 | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS A | St. Jude Medical Systems AB | 2014-11-13 | 262 | 0 |
| K133587 | PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 3 | St. Jude Medical Systems AB | 2013-12-20 | 29 | 0 |
| K131452 | PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 | St. Jude Medical Systems AB | 2013-09-05 | 108 | 0 |
| K111854 | AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE | St. Jude Medical Systems AB | 2011-10-21 | 114 | 0 |
| K110193 | FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOS | St. Jude Medical Systems AB | 2011-02-24 | 31 | 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