Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Karl Storz Imaging, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
185 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003325 | KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM | Karl Storz Imaging, Inc. | 2001-04-27 | 185 | 0 |
| K001362 | KARL STORZ 3D VIDEO SYSTEM | Karl Storz Imaging, Inc. | 2000-07-17 | 80 | 0 |
| K994090 | KARL STORZ AUTOCLAVABLE CAMERA HEAD | Karl Storz Imaging, Inc. | 2000-02-04 | 63 | 0 |
| K990154 | KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM | Karl Storz Imaging, Inc. | 1999-06-01 | 133 | 0 |
| K974391 | KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM | Karl Storz Imaging, Inc. | 1998-01-30 | 70 | 0 |
| K973252 | KARL STORZ DIRECT COUPLED CAMERA HEAD | Karl Storz Imaging, Inc. | 1997-11-24 | 87 | 0 |
| K963333 | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) | Karl Storz Imaging, Inc. | 1996-10-22 | 60 | 0 |
| K950862 | KARL STORZ ENDOVISION TRICAM, MODEL 20221101 (20221001, PAL | Karl Storz Imaging, Inc. | 1995-05-24 | 86 | 0 |
| K950975 | KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE | Karl Storz Imaging, Inc. | 1995-05-11 | 70 | 0 |
| K950974 | KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) AC | Karl Storz Imaging, Inc. | 1995-05-11 | 70 | 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