Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NAY · Predicate Candidate Screening
165 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
268 days90th percentile
165clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261824 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | 2026-07-31 | 60 | 0 |
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | 2026-05-22 | 80 | 0 |
| K254192 | Senhance Ultrasonic System | Asensus Surgical | 2026-05-12 | 140 | 0 |
| K253986 | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | 2026-03-11 | 89 | 0 |
| K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2026-01-16 | 224 | 0 |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generat | Intuitive Surgical, Inc. | 2026-01-16 | 63 | 0 |
| K252675 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-15 | 112 | 0 |
| K252069 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-02 | 154 | 0 |
| K251426 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-10-03 | 148 | 0 |
| K251817 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-09-10 | 89 | 0 |
| K251227 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-09-08 | 140 | 0 |
| K251324 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-08-29 | 122 | 0 |
| K252350 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2025-08-28 | 30 | 0 |
| K250442 | da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. | 2025-07-29 | 165 | 0 |
| K251213 | Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-23 | 96 | 0 |
| K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-16 | 89 | 0 |
| K250674 | Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. | 2025-06-13 | 99 | 0 |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical Sy | Intuitive Surgical, Inc. | 2025-06-11 | 440 | 0 |
| K250786 | SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. | 2025-05-13 | 60 | 0 |
| K243714 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-04-24 | 143 | 0 |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical Sy | Intuitive Surgical, Inc. | 2025-04-01 | 229 | 0 |
| K243582 | da Vinci SP Advanced Access Port Kit (432701) | Intuitive Surgical, Inc. | 2025-02-28 | 100 | 0 |
| K243641 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024-12-16 | 20 | 0 |
| K242318 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-11-26 | 113 | 0 |
| K241814 | da Vinci SP Instruments (SP1098) | Intuitive Surgical, Inc. | 2024-11-18 | 147 | 0 |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; | Intuitive Surgical, Inc. | 2024-09-10 | 95 | 1 |
| K233866 | Senhance Surgical System | Asensus Surgical, Inc. | 2024-07-19 | 226 | 0 |
| K240502 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-07-08 | 138 | 0 |
| K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024-07-03 | 57 | 0 |
| K232773 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2024-06-04 | 267 | 0 |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical Sy | Intuitive Surgical | 2024-05-24 | 67 | 0 |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator | Intuitive Surgical, Inc. | 2024-03-14 | 199 | 6 |
| K231798 | da Vinci SP Surgical System | Intuitive Surgical, Inc. | 2023-11-08 | 141 | 0 |
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical Sy | Intuitive Surgical, Inc. | 2023-05-12 | 14 | 0 |
| K230033 | Da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2023-04-05 | 90 | 0 |
| K223095 | Senhance Surgical System | Asensus Surgical, Inc. | 2023-03-16 | 167 | 1 |
| K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, Su | Intuitive Surgical, Inc. | 2023-03-16 | 177 | 1 |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical Sy | Intuitive Surgical, Inc. | 2022-11-22 | 53 | 0 |
| K222827 | da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2022-10-20 | 31 | 0 |
| K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | Intuitive Surgical, Inc. | 2022-08-15 | 230 | 12 |
| K220889 | Senhance Surgical System | Asensus Surgical, Inc. | 2022-05-27 | 60 | 0 |
| K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefl | Intuitive Surgical, Inc. | 2022-02-17 | 85 | 0 |
| K220023 | 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. | 2022-01-31 | 26 | 1 |
| K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Staple | Intuitive Surgical, Inc. | 2021-12-10 | 165 | 2 |
| K212101 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2021-11-23 | 140 | 0 |
| K212747 | Da Vinci SP Surgical System | Intuitive Surgical, Inc. | 2021-09-29 | 30 | 0 |
| K212054 | Senhance Surgical System | Asensus Surgical, Inc. | 2021-08-30 | 61 | 0 |
| K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical Sy | Intuitive Surgical, Inc. | 2021-08-06 | 58 | 0 |
| K211325 | Senhance Surgical System | Asensus Surgical, Inc. | 2021-07-27 | 88 | 0 |
| K211316 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2021-07-23 | 84 | 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