Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Veran Medical Technologies, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
185 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202346 | SPiN Vision Video Bronchoscope System | Veran Medical Technologies, Inc. | 2021-02-19 | 185 | 0 |
| K170023 | SPiN Thoracic Navigation System | Veran Medical Technologies, Inc. | 2017-05-15 | 132 | 15 |
| K122106 | SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-O | Veran Medical Technologies, Inc. | 2012-12-21 | 157 | 13 |
| K093995 | IG 4 IMAGE GUIDED SYSTEM | Veran Medical Technologies, Inc. | 2010-01-27 | 30 | 0 |
| K091934 | IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACC | Veran Medical Technologies, Inc. | 2009-12-02 | 155 | 0 |
| K093146 | IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 | Veran Medical Technologies, Inc. | 2009-11-30 | 56 | 5 |
| K060903 | IG4 IMAGE GUIDED SYSTEM | Veran Medical Technologies, Inc. | 2006-05-11 | 38 | 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