Lexington Medical, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Lexington Medical, Inc.” (first 2017, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Since 2017 the median was 89 days, against 108 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 170 |
| 2018 | 3 | 87 |
| 2019 | 1 | 53 |
| 2020 | 1 | 93 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 270 |
| 2024 | 1 | 138 |
| 2025 | 1 | 58 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lexington Medical, Inc. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GDW | Staple, Implantable | 5 | 5 |
| GAG | Stapler, Surgical | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Lexington Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251482 | AEON Endoscopic Powered Stapler | GAG | 2025-07-11 | 58 |
| K234039 | AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) | GAG | 2024-05-07 | 138 |
| K222210 | AEON Endoscopic Stapler | GDW | 2023-04-21 | 270 |
| K201882 | AEON Endoscopic Stapler | GDW | 2020-10-09 | 93 |
| K192235 | AEON Laparoscopic Instruments | GEI | 2019-10-11 | 53 |
| K182380 | AEON Endoscopic Stapler | GDW | 2018-11-28 | 89 |
| K180114 | AEON Retrieval Bag | GCJ | 2018-03-27 | 70 |
| K173443 | AEON Endoscopic Stapler | GDW | 2018-02-01 | 87 |
| K171589 | AEON Endoscopic Stapler | GDW | 2017-11-17 | 170 |
Recalls
openFDA lists no recalls under a recalling firm named Lexington Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Lexington Medical, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06474637: Powered Handle Primary Sleeve Gastrectomy Study (Recruiting, started 2024-01-30)
- NCT05143541: Use of a New Stapling Device in General Thoracic Surgery (Completed, started 2021-03-01)
- NCT04617574: Endostapler Sleeve Gastrectomy Study (Completed, started 2020-09-15)
- NCT04149925: Endostapler Hemostasis Study (Completed, started 2019-10-22)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Lexington International, LLC (8 510(k)s)
- Lexington Industries (2 510(k)s)
- Lexington Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lexington Medical, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Lexington Medical, Inc.” (first 2017, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lexington Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lexington Medical, Inc. is 89 days. Since 2017: 89 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lexington Medical, Inc.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 5); GAG (Stapler, Surgical, 2); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 9 Lexington Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Lexington Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.