Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GCJ — Predicate Candidate Screening
1,426 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
245 days90th percentile
1,426clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253541 | EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX P | Medical Impact | 2026-07-24 | 252 | 0 |
| K261614 | LED LCD Monitor (OEV-271H) | Lg Electronics.Inc | 2026-07-17 | 63 | 0 |
| K261249 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-07-14 | 89 | 0 |
| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShiel | FloShield, Inc. | 2026-06-11 | 99 | 0 |
| K260414 | “Tech-Image” Video Endoscope System | Tech-Image CO., LTD. | 2026-06-10 | 121 | 0 |
| K253994 | TroKit Laparoscope Lens Wiper | TroCare, LLC | 2026-06-04 | 174 | 0 |
| K252532 | Inno-Port Disposable Bladed Trocar | Taiwan Surgical Corporation | 2026-06-02 | 294 | 0 |
| K260318 | 4K NIR/ICG Imaging System | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 | 116 | 0 |
| K260183 | MediBot Needle Driver Uno | Parallel Robotics, LLC | 2026-05-24 | 123 | 0 |
| K252985 | Laport | Sejong Medical Co., Ltd. | 2026-05-19 | 243 | 0 |
| K254228 | KARL STORZ Trocars with Valve Seals | Karl Storz SE & CO. KG | 2026-05-11 | 136 | 0 |
| K252858 | 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KM | Kms Medical Technology Co., Ltd. | 2026-04-30 | 233 | 0 |
| K260197 | Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 12 | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 | 76 | 0 |
| K260089 | TL-10 Laparoscopic Scope Cleaner | Scopix , Ltd. | 2026-04-08 | 86 | 0 |
| K252714 | C-Lant Port | Vigor Medical Technologies , Ltd. | 2026-02-27 | 184 | 0 |
| K253978 | Universal Seal (5-12 mm) | Intuitive Surgical, Inc. | 2026-02-24 | 74 | 0 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4 | Stryker Endoscopy | 2026-02-18 | 28 | 0 |
| K260177 | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Process | Xenocor, Inc. | 2026-02-12 | 22 | 0 |
| K251923 | Medical Shaver System (Morcellator) (YSB-IIIA) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 | 220 | 0 |
| K252957 | Pneumo Dissector Hook | Ab Medica Sas | 2026-01-23 | 129 | 0 |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Inform | Stryker Endoscopy | 2026-01-13 | 29 | 0 |
| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | 2025-11-22 | 239 | 0 |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025-11-20 | 447 | 0 |
| K252442 | Kii Structural Balloon Access System | Applied Medical Resources Corp. | 2025-10-31 | 88 | 0 |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | 2025-10-29 | 63 | 0 |
| K252640 | VereSee Optical Veres Needle and Endoscopic Camera | Freyja Healthcare, LLC | 2025-10-20 | 60 | 0 |
| K251994 | Arthrex Synergy Vision Imaging System | Arthrex, Inc. | 2025-10-16 | 111 | 0 |
| K243968 | Revolve Surgical System | Revolve Surgical, Inc. | 2025-10-03 | 284 | 0 |
| K250551 | 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-80 | Shenzhen Sophway Technology Co., Ltd. | 2025-10-02 | 219 | 0 |
| K251743 | SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specime | Surgical Principals, Inc. | 2025-09-22 | 108 | 0 |
| K250130 | Viction Disposable Irrigation and suction System (VC-FLA0514 | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 | 201 | 0 |
| K250124 | Viction Disposable Irrigation and suction catheter (VC-IRA05 | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 | 201 | 0 |
| K252010 | SPY Laparoscope | Stryker Endoscopy | 2025-07-24 | 27 | 0 |
| K250820 | Disposable Trocars | Sinolinks Medical Innovation, Inc. | 2025-07-11 | 115 | 0 |
| K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | Intuitive Surgical, Inc. | 2025-07-02 | 49 | 0 |
| K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | 2025-07-02 | 244 | 0 |
| K251209 | Medical Monitor (32HS710S) | Lg Electronics.Inc | 2025-06-12 | 55 | 0 |
| K250728 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2025-05-05 | 55 | 0 |
| K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | 2025-03-17 | 90 | 0 |
| K250411 | DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Syst | Dannik, LLC | 2025-03-12 | 27 | 0 |
| K243439 | Medical Monitor (27HS714S) | Lg Electronics.Inc | 2025-01-28 | 83 | 0 |
| K243008 | Arthrex NanoScope System | Arthrex, Inc. | 2025-01-22 | 118 | 0 |
| K243307 | LCD Monitor (MDEC-2523) | Barco N.V. | 2024-12-13 | 53 | 0 |
| K242927 | Suction Irrigation Tubing Set | Advamedix, GmbH | 2024-11-22 | 59 | 0 |
| K240831 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2024-11-06 | 225 | 0 |
| K240334 | LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670 | Lagis Enterprise Co., Ltd. | 2024-10-30 | 268 | 0 |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K | Guangdong Optomedic Technologies, Inc. | 2024-10-23 | 61 | 0 |
| K241052 | Bladeless Trocar; Bladed Trocar; Hasson Trocar | Advamedix, GmbH | 2024-10-04 | 170 | 0 |
| K241796 | TroCare TroKit Laparoscope Lens Wiper (CP000626) | TroCare, LLC | 2024-10-04 | 105 | 0 |
| K241913 | da Vinci Handheld Camera | Intuitive Surgical Operations, Inc. | 2024-08-28 | 58 | 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