Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PEA — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
212 daysmedian FDA review time
266 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Pentax of America, Inc. | 2025-06-03 | 53 | 1 |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Vi | Pentax of America, Inc. | 2023-07-28 | 88 | 4 |
| K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Vi | Pentax of America, Inc. | 2019-12-20 | 266 | 0 |
| K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processo | Pentax of America, Inc. | 2019-11-08 | 179 | 0 |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of S | Pentax of America, Inc. | 2018-07-03 | 214 | 0 |
| K160275 | Fuse Endoscopic System with FuseBox Processor | Endochoice, Inc. | 2016-08-01 | 181 | 0 |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Pentax of America, Inc. | 2015-11-24 | 259 | 0 |
| K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR | Fujifilm Medical Systems U.S.A, Inc. | 2014-08-22 | 212 | 0 |
| K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | Pentax Medical | 2013-04-10 | 240 | 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