Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KARL STORZ SE & CO. KG · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
267 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261706 | Endomat Select (UP220) | KARL STORZ SE & CO. KG | 2026-07-16 | 55 | 0 |
| K252800 | KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG | 2026-06-03 | 273 | 0 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 | 136 | 0 |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | 2026-03-02 | 59 | 0 |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026-02-26 | 59 | 0 |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | 2026-02-12 | 63 | 0 |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FI | Karl Storz SE & CO. KG | 2025-12-05 | 182 | 0 |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | 2025-11-22 | 239 | 0 |
| K253411 | Miniature Telescope for Urology (27033AA) | Karl Storz SE & CO. KG | 2025-11-18 | 49 | 0 |
| K250388 | ENDOFLATOR + | Karl Storz SE & CO. KG | 2025-09-22 | 223 | 0 |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & CO. KG | 2025-08-13 | 260 | 0 |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG | 2025-06-06 | 203 | 0 |
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ C | Karl Storz SE & CO. KG | 2025-05-02 | 127 | 0 |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG | 2024-11-27 | 26 | 0 |
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL ST | Karl Storz SE & CO. KG | 2024-08-01 | 29 | 0 |
| K233372 | KARL STORZ Fiber Telescopes for Urology | Karl Storz SE & CO. KG | 2024-07-25 | 297 | 14 |
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG | 2024-05-07 | 265 | 0 |
| K232370 | Percutaneous Nephroscope System | Karl Storz SE & CO. KG | 2024-05-01 | 267 | 8 |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Con | Karl Storz SE & CO. KG | 2023-11-21 | 53 | 0 |
| K232857 | KARL STORZ ICG Imaging System | Karl Storz SE & CO. KG | 2023-11-06 | 52 | 0 |
| K232406 | KARL STORZ OR1™ SCB CONTROL (WU300) | Karl Storz SE & CO. KG | 2023-10-03 | 54 | 0 |
| K230535 | KARL STORZ Urological Laser Accessories | Karl Storz SE & CO. KG | 2023-09-08 | 193 | 0 |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020-07-22 | 62 | 0 |
| K192090 | CMOS Video Rhino-Laryngoscope SSU | Karl Storz SE & CO. KG | 2020-01-27 | 175 | 0 |
| K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | 2020-01-24 | 133 | 0 |
| K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018-10-31 | 223 | 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