Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OWN — Predicate Candidate Screening
62 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
267 days90th percentile
62clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254180 | PerfusiX-Imaging | LIMIS Development B.V. | 2026-07-24 | 213 | 0 |
| K242163 | SmartSurgN Visualization System | SmartsurgN, Inc. | 2026-04-20 | 635 | 0 |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026-02-26 | 59 | 0 |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1 | VPIX Medical, Inc. | 2026-02-13 | 241 | 0 |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & CO. KG | 2026-02-12 | 63 | 0 |
| K260108 | L12 LED Light Source with AIM | Stryker Endoscopy | 2026-02-12 | 29 | 0 |
| K251336 | VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S | Olympus Medical Systems Corp. | 2025-11-12 | 196 | 0 |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Mi | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-07-24 | 234 | 0 |
| K243591 | OPTOVISION Endoscopic Light Source Unit | Optosurgical, LLC | 2025-02-19 | 91 | 0 |
| K241275 | Histolog® Scanner (Hardware 2.4, Software 3.3) | Samantree Medical SA | 2024-08-19 | 105 | 0 |
| 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 |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LE | Stryker | 2023-09-20 | 89 | 0 |
| K231344 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | 2023-08-02 | 85 | 0 |
| K230407 | FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | 2023-07-17 | 152 | 0 |
| K230754 | L12 LED Light Source with AIM | Stryker | 2023-04-11 | 25 | 0 |
| K213943 | SmartSurgN Visualization System | Smartsurgn Incorporated | 2022-11-29 | 347 | 0 |
| K223020 | VS3-Iridium System (VS3-IR) | Visionsense, Ltd. | 2022-10-28 | 29 | 0 |
| K221611 | 780 nm L11 LED Light Source with AIM | Stryker | 2022-06-29 | 26 | 0 |
| K220477 | Cellvizio 100 series system with confocal Miniprobes | Mauna Kea Technologies | 2022-04-11 | 52 | 0 |
| K210265 | VS3 Iridium Sytem | Visionsense, Ltd. | 2021-11-22 | 294 | 0 |
| K212695 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America | 2021-11-15 | 82 | 0 |
| K212322 | Cellvizio I.V.E. system with Confocal Miniprobes | Mauna Kea Technologies | 2021-08-18 | 23 | 0 |
| K203550 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | 2021-04-08 | 125 | 0 |
| K202925 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy_America, Inc. | 2020-12-17 | 79 | 0 |
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-11-05 | 87 | 0 |
| K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45 | Karl Storz-Endoscopy-America, Inc. | 2020-08-17 | 81 | 0 |
| K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope U | Olympus Medical Systems Corp. | 2020-07-17 | 136 | 0 |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-05-21 | 59 | 0 |
| K193416 | Cellvizio I.V.E. with Confocal Miniprobes | Mauna Kea Technologies | 2020-02-28 | 81 | 0 |
| K191144 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2020-01-24 | 269 | 0 |
| K191851 | VS3-IR | Medtronic | 2019-11-25 | 138 | 0 |
| K192292 | L10 LED Light Source with AIM, L11 LED Light Source with AIM | Stryker | 2019-11-19 | 88 | 0 |
| K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-11-15 | 95 | 0 |
| K191046 | L10 LED Light Source with AIM, L11 LED Light Source with AIM | Stryker | 2019-05-10 | 21 | 0 |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019-04-19 | 29 | 0 |
| K183453 | VS3-IR | Medtronic | 2019-03-04 | 81 | 0 |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and thei | Mauna Kea Technologies | 2019-02-22 | 58 | 0 |
| K173866 | Stryker AIM Light Source and SafeLight cable | Stryker | 2018-01-18 | 29 | 0 |
| K172844 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2017-12-15 | 87 | 0 |
| K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | 2017-08-04 | 88 | 0 |
| K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017-05-25 | 28 | 0 |
| K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017-01-26 | 104 | 0 |
| K162885 | SPY Phi Open Field Handheld Fluorescence Imaging System | Novadaq Technologies, Inc. | 2017-01-11 | 86 | 0 |
| K152583 | KARL STORZ Endoscopic ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2016-05-31 | 264 | 0 |
| K160416 | CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series ( | Mauna Kea Technologies | 2016-05-20 | 94 | 0 |
| K150831 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015-12-22 | 267 | 0 |
| K152204 | VS3-IR system | Visionsense, Ltd. | 2015-10-28 | 83 | 0 |
| K151593 | Cellvizio 100 Series System with Confocal Miniprobes | Mauna Kea Technologies | 2015-10-23 | 133 | 0 |
| K143474 | Artemis Hand Held Imaging System | Quest Medical Imaging | 2015-06-30 | 207 | 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