Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KARL STORZ Endoscopy-America, Inc. · Predicate Candidate Screening
362 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
262 days90th percentile
362clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | 2026-05-15 | 270 | 0 |
| K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024-10-22 | 244 | 0 |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2023-09-14 | 261 | 0 |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig | Karl Storz Endoscopy America, Inc. | 2023-06-23 | 133 | 0 |
| K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | 2023-04-27 | 155 | 0 |
| K223923 | HOPKINS Telescopes | KARL STORZ Endoscopy-America, Inc. | 2023-03-30 | 90 | 0 |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | 2023-03-17 | 261 | 0 |
| K221004 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2022-12-20 | 259 | 0 |
| K222504 | H1 | Karl Storz Endoscopy America, Inc. | 2022-11-10 | 84 | 0 |
| K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2022-06-23 | 267 | 0 |
| K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | 2022-05-13 | 18 | 0 |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy America, Inc. | 2021-09-03 | 28 | 0 |
| K203198 | KARL STORZ Metal Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021-07-06 | 250 | 1 |
| K202272 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2021-05-11 | 273 | 0 |
| K203572 | Karl Storz Radel Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021-05-07 | 151 | 1 |
| K201945 | KARL STORZ UDEL Sterilization Trays | Karl Storz Endoscopy America, Inc. | 2021-02-25 | 227 | 0 |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | 2020-12-29 | 263 | 0 |
| K202925 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy_America, Inc. | 2020-12-17 | 79 | 0 |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | KARL STORZ Endoscopy-America, Inc. | 2020-10-29 | 29 | 0 |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillC | KARL STORZ Endoscopy-America, Inc. | 2020-10-22 | 258 | 0 |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | 2020-09-01 | 126 | 0 |
| K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45 | Karl Storz-Endoscopy-America, Inc. | 2020-08-17 | 81 | 0 |
| K200740 | HD Video Rhino Laryngoscope | KARL STORZ Endoscopy-America, Inc. | 2020-08-11 | 141 | 0 |
| K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | 2020-06-23 | 60 | 0 |
| K193235 | Telepack + | Karl Storz Endoscopy America, Inc. | 2019-12-20 | 25 | 0 |
| K191357 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019-09-18 | 120 | 0 |
| K182723 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019-04-23 | 207 | 0 |
| K182186 | CMOS Video-Rhino-Laryngoscope System | KARL STORZ Endoscopy-America, Inc. | 2019-03-22 | 221 | 0 |
| K183264 | Flex-THOR scope | KARL STORZ Endoscopy-America, Inc. | 2019-01-18 | 56 | 0 |
| K182696 | Telepack X LED | KARL STORZ Endoscopy-America, Inc. | 2018-11-20 | 54 | 0 |
| K180977 | KARL STORZ New Generation Trocars | KARL STORZ Endoscopy-America, Inc. | 2018-07-18 | 96 | 0 |
| K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018-04-17 | 89 | 0 |
| K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | KARL STORZ Endoscopy-America, Inc. | 2018-02-02 | 266 | 0 |
| K171717 | AUTOCON III 400 | KARL STORZ Endoscopy-America, Inc. | 2017-08-02 | 54 | 0 |
| K162992 | Karl Storz UROMAT E.A.S.I. | Karl Storz Endoscopy America, Inc. | 2017-07-07 | 253 | 0 |
| K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017-05-25 | 28 | 0 |
| K170462 | KARL STORZ ShuntScope | KARL STORZ Endoscopy-America, Inc. | 2017-05-16 | 90 | 0 |
| K162880 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017-03-16 | 153 | 0 |
| K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | KARL STORZ Endoscopy-America, Inc. | 2017-03-02 | 269 | 0 |
| K162410 | TIPCAM 1S 3D System | Karl Storz Endoscopy America, Inc. | 2017-03-02 | 185 | 0 |
| K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017-01-26 | 104 | 0 |
| K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | Karl Storz Endoscopy America, Inc. | 2016-10-21 | 137 | 0 |
| K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | KARL STORZ Endoscopy-America, Inc. | 2016-09-17 | 150 | 0 |
| K152583 | KARL STORZ Endoscopic ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2016-05-31 | 264 | 0 |
| K160044 | Image1 SPIES System | Karl Storz Endoscopy America, Inc. | 2016-02-01 | 24 | 0 |
| K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut- | Karl Storz Endoscopy America, Inc. | 2016-01-08 | 270 | 0 |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 S | KARL STORZ Endoscopy-America, Inc. | 2015-11-20 | 263 | 0 |
| K151044 | CLICKLINE Scissor Insert for Single Use | Karl Storz Endoscopy America, Inc. | 2015-10-09 | 172 | 0 |
| K143640 | KSEA CMOS Camera System (C-cam) | KARL STORZ Endoscopy-America, Inc. | 2015-09-17 | 269 | 0 |
| K142556 | Flexible Video-Uretero-Choledochoscope System | KARL STORZ Endoscopy-America, Inc. | 2014-10-23 | 42 | 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