Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Interrad Medical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
449 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210629 | SecurAcath | Interrad Medical, Inc. | 2021-04-12 | 41 | 0 |
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F | Interrad Medical, Inc. | 2019-07-09 | 449 | 0 |
| K180769 | SecurAcath | Interrad Medical, Inc. | 2018-06-26 | 95 | 0 |
| K120935 | SECURACATH | Interrad Medical, Inc. | 2012-04-27 | 30 | 0 |
| K092306 | SECURACATH UNIVERSAL | Interrad Medical, Inc. | 2010-07-09 | 345 | 0 |
| K083081 | MODIFICATION TO SECURACATH, MODEL: SPK01 | Interrad Medical, Inc. | 2009-03-04 | 139 | 0 |
| K082047 | SECURACATH CATHETER, MODEL SPK01 | Interrad Medical, Inc. | 2008-09-30 | 74 | 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