Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Innovision A/S · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102047 | LCI OPTION FOR INNOCOR | Innovision A/S | 2011-11-01 | 468 | 1 |
| K083879 | INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR | Innovision A/S | 2009-02-23 | 56 | 0 |
| K071911 | CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR | Innovision A/S | 2007-09-07 | 58 | 0 |
| K051907 | INNOCOR | Innovision A/S | 2006-03-02 | 231 | 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