Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Karl Storz Endoscopy America · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
348 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212458 | Flexible Video-Uretero-Renoscope SSU System | Karl Storz Endoscopy America | 2022-01-20 | 168 | 0 |
| K212656 | Flexible Intubation Video Endoscope – Sterile (FIVE-S) | Karl Storz Endoscopy America | 2021-12-29 | 128 | 1 |
| K212695 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America | 2021-11-15 | 82 | 0 |
| K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021-03-30 | 348 | 0 |
| K201526 | TIPCAM1 Rubina Video Endoscope System | Karl Storz Endoscopy America | 2020-11-20 | 165 | 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