Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intuitive Surgical — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
221 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | 2026-05-22 | 80 | 0 |
| K241635 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2024-08-05 | 60 | 0 |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Intuitive Surgical | 2024-08-02 | 58 | 0 |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical Sy | Intuitive Surgical | 2024-05-24 | 67 | 0 |
| K231212 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2023-06-21 | 54 | 0 |
| K223039 | da Vinci E-200 Electrosurgical Generator | Intuitive Surgical | 2022-11-28 | 60 | 0 |
| K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical | 2020-04-29 | 212 | 0 |
| K191529 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical | 2020-02-06 | 241 | 0 |
| K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endos | Intuitive Surgical | 2019-07-26 | 28 | 0 |
| K182643 | IRIS 1.0 System | Intuitive Surgical | 2019-02-22 | 151 | 0 |
| K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019-02-14 | 185 | 1 |
| K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | 2019-01-18 | 59 | 0 |
| K173721 | SureForm 60 and SureForm 60 Reloads | Intuitive Surgical | 2018-07-05 | 212 | 0 |
| K152892 | da Vinci Xi Surgical System | Intuitive Surgical | 2016-04-29 | 212 | 0 |
| K141075 | SINGLE-SITE WRISTED NEEDLE DRIVER | Intuitive Surgical | 2014-09-26 | 154 | 0 |
| K133942 | ENDOSCOPE STERILIZATION TRAY | Intuitive Surgical | 2014-08-01 | 221 | 0 |
| K133845 | 8MM TROCAR KIT | Intuitive Surgical | 2014-02-19 | 63 | 1 |
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