Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EOX — Predicate Candidate Screening
30 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
210 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102) | Cyted Limited | 2024-01-19 | 114 | 0 |
| K230339 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2023-02-24 | 17 | 0 |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | 2022-12-02 | 63 | 0 |
| K222366 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2022-10-26 | 83 | 0 |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed fro | Capnostics, LLC | 2021-05-04 | 162 | 2 |
| K210137 | EsoCheck Cell Collection Device | Lucid Diagnostics, Inc. | 2021-02-18 | 30 | 0 |
| K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | 2020-01-24 | 133 | 0 |
| K183262 | EsoCheck CCD Cell Collection Device | Lucid Diagnostics, Inc. | 2019-06-21 | 210 | 0 |
| K182159 | Strome-Blitzer Cytology Balloon | Adn International, LLC | 2019-06-13 | 308 | 0 |
| K181292 | PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 91 | Cogentix Medical, Inc. | 2018-11-15 | 183 | 0 |
| K181020 | Cytosponge Cell Collection Device | Covidien, LLC | 2018-08-16 | 121 | 1 |
| K152794 | Cytosponge Cell Collection Device | Covidien, LLC | 2016-04-12 | 197 | 0 |
| K142695 | Cytosponge Cell Collection Device | Covidien, LLC | 2014-11-26 | 65 | 0 |
| K131131 | E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2013-06-21 | 60 | 0 |
| K120702 | E.G. SCAN II ESPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2012-06-20 | 104 | 0 |
| K111030 | E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM | Intromedic Co., Ltd. | 2011-10-21 | 191 | 0 |
| K072088 | FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO | Vision-Sciences, Inc. | 2007-08-29 | 30 | 0 |
| K071903 | ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE | Vision-Sciences, Inc. | 2007-08-02 | 23 | 0 |
| K051972 | KARL STORZ TRANS-NASAL ESOPHAGOSCOPE | KARL STORZ Endoscopy-America, Inc. | 2005-08-15 | 25 | 0 |
| K031786 | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM | Vision-Sciences, Inc. | 2003-08-05 | 56 | 0 |
| K953849 | PRISM ELECTROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1995-09-06 | 21 | 0 |
| K951395 | KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES | KARL STORZ Endoscopy-America, Inc. | 1995-05-09 | 42 | 0 |
| K951424 | M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM | M.E.R. Surgical Co. | 1995-05-09 | 43 | 0 |
| K946331 | KARL STORZ BOUGIES, SOUNDS, DILATORS | KARL STORZ Endoscopy-America, Inc. | 1995-03-02 | 63 | 0 |
| K945237 | KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE | KARL STORZ Endoscopy-America, Inc. | 1994-12-21 | 55 | 0 |
| K943667 | ESOPHAGOSCOPE AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1994-08-18 | 21 | 0 |
| K934193 | CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST | Biosearch Medical Products, Inc. | 1993-11-19 | 85 | 0 |
| K911588 | BRANDT ESOPHAGEAL CYTOLOGY BALLOON | Wilson-Cook Medical, Inc. | 1992-11-18 | 589 | 0 |
| K892259 | JESBERG ESOPHAGOSCOPE | Zinnanti Surgical Instruments, Inc. | 1989-06-16 | 73 | 0 |
| K760652 | JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S | Pilling Co. | 1976-12-16 | 92 | 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