Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EWY — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
267 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260003 | KARL STORZ Mediastinoscopes and Instruments | Karl Storz SE & CO. KG | 2026-03-02 | 59 | 0 |
| K213194 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2022-06-23 | 267 | 0 |
| K202272 | HD Mediastinoscope | Karl Storz Endoscopy America, Inc. | 2021-05-11 | 273 | 0 |
| K170757 | Aegis Transit System | Boston-Biomedical Associates | 2017-07-14 | 123 | 0 |
| K160171 | Illuminated Mediastinal Access Port | Aegis Surgical, Ltd. | 2016-02-26 | 30 | 0 |
| K141622 | ILLUMINATED MEDIASTINOSCOPE | Aegis Surgical, Ltd. | 2015-01-09 | 206 | 0 |
| K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPI | Richard Wolf Medical Instruments Corp. | 1997-08-27 | 149 | 0 |
| K954910 | KARL STORZ OPTICAL MEDIASTINOSCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-11-03 | 9 | 0 |
| K930215 | FLEXIBLE TROCAR TUBES | Olympus Corp. | 1993-03-16 | 61 | 0 |
| K913829 | OLYMPUS FLEXIBLE TIP THORACOSCOPE | Olympus Corp. | 1991-11-22 | 88 | 0 |
| K912362 | OES THORACOSCOPE SYSTEM | Olympus Corp. | 1991-10-24 | 148 | 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