Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lexington Medical, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
270 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251482 | AEON™ Endoscopic Powered Stapler | Lexington Medical, Inc. | 2025-07-11 | 58 | 0 |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endosc | Lexington Medical, Inc. | 2024-05-07 | 138 | 0 |
| K222210 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2023-04-21 | 270 | 0 |
| K201882 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2020-10-09 | 93 | 0 |
| K192235 | AEON Laparoscopic Instruments | Lexington Medical, Inc. | 2019-10-11 | 53 | 0 |
| K182380 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018-11-28 | 89 | 0 |
| K180114 | AEON Retrieval Bag | Lexington Medical, Inc. | 2018-03-27 | 70 | 0 |
| K173443 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2018-02-01 | 87 | 0 |
| K171589 | AEON Endoscopic Stapler | Lexington Medical, Inc. | 2017-11-17 | 170 | 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