Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FDF — Predicate Candidate Screening
113 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
268 days90th percentile
113clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261587 | Insufflation Retention Device (IRD) (11173-325-101) | BPEndo, LLC | 2026-07-02 | 50 | 0 |
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 | 108 | 0 |
| K252457 | Disposable Distal End Tape Hood | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 | 178 | 0 |
| K244029 | ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) | Endorobotics Co., Ltd. | 2025-09-24 | 268 | 0 |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model | Fujifilm Corporation | 2025-05-23 | 220 | 0 |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500D | Olympus Medical Systems Corporation | 2025-05-15 | 90 | 0 |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | Pentax of America, Inc. | 2025-01-03 | 168 | 0 |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI Models | Actuated Medical, Inc. | 2024-10-04 | 59 | 0 |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V200 | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-16 | 221 | 0 |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | 2023-11-03 | 186 | 0 |
| K232922 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2023-10-20 | 31 | 0 |
| K230332 | Ambu® aScope™ Colon; Ambu® aBox™ 2 | Ambu A/S | 2023-09-15 | 220 | 0 |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Prog | Fujifilm Corporation | 2023-09-08 | 261 | 0 |
| K230588 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | 2023-08-17 | 168 | 0 |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023-02-10 | 268 | 0 |
| K213773 | Insufflation Retention Device | Bpendo, LLC | 2022-07-21 | 231 | 0 |
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | 2022-04-11 | 82 | 0 |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | 2022-04-06 | 147 | 0 |
| K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band Im | Saneso, Inc. | 2022-04-01 | 448 | 0 |
| K220007 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | 2022-02-10 | 37 | 0 |
| K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021-10-22 | 133 | 0 |
| K210981 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2021-04-29 | 28 | 0 |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | 2021-04-21 | 30 | 0 |
| K202469 | G-EYE System | Smart Medical Systems , Ltd. | 2020-10-26 | 60 | 0 |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exe | Olympus Medical Systems Corp. | 2020-07-17 | 291 | 3 |
| K192588 | G-EYE System | Smart Medical Systems , Ltd. | 2020-04-15 | 209 | 0 |
| K190669 | Endotics | Era Endoscopy S.R.L. | 2020-01-03 | 294 | 0 |
| K192664 | FUJIFILM Endoscope Model EC-760Z-V/L | Fujifilm Corporation | 2019-11-20 | 56 | 0 |
| K191220 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2019-06-06 | 30 | 0 |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | Fujifilm Corporation | 2019-05-07 | 55 | 0 |
| K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | 2019-01-18 | 269 | 0 |
| K182540 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2018-10-30 | 46 | 0 |
| K180285 | PENTAX Medical Video Colonoscope EC34-i10T Series | Pentax Medical of America, Inc. | 2018-10-26 | 267 | 0 |
| K181437 | Pure Vu System | Motus GI Medical Technologies , Ltd. | 2018-06-21 | 20 | 0 |
| K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | 2018-04-17 | 180 | 0 |
| K180405 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Corporation | 2018-03-15 | 29 | 0 |
| K171673 | Focus Cap | Gce Medical Corporation | 2018-01-19 | 227 | 0 |
| K173085 | invendoscopy E210 System | Invendo Medical GmbH | 2018-01-08 | 101 | 0 |
| K173392 | Pure-Vu System | Motus GI Medical Technologies , Ltd. | 2017-12-12 | 43 | 0 |
| K172036 | Medrobotics Flex Robotic System | Medrobotics Corporation | 2017-08-03 | 29 | 0 |
| K162330 | Flex Robotic System and Flex Colorectal Drive | Medrobotics Corporation | 2017-05-04 | 258 | 0 |
| K163492 | Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radia | United States Endoscopy Group, Inc. | 2017-01-06 | 24 | 0 |
| K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2016-12-06 | 98 | 0 |
| K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | 2016-10-18 | 28 | 0 |
| K160015 | Pure Vu | Motus GI Medical Technologies , Ltd. | 2016-09-22 | 262 | 0 |
| K161355 | invendoscopy E200 System | Invendo Medical GmbH | 2016-08-25 | 101 | 0 |
| K161791 | Aer-O-Scope Colonoscope System | Gi View , Ltd. | 2016-08-11 | 43 | 0 |
| K160356 | Third Eye Panoramic Auxiliary Endoscopy System - Resposable | Avantis Medical Systems, Inc. | 2016-05-17 | 99 | 0 |
| K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-23 | 27 | 0 |
| K153483 | Balloon controller PB-30 | Fujifilm Medical Systems U.S.A, Inc. | 2015-12-15 | 12 | 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