Ameco Medical Industries: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ameco Medical Industries” (first 2011, latest 2016), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 122 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 103 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 130 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 1 | 1 |
Review panels
Most recent Ameco Medical Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152819 | Amecath Peripheral inserted Central Venous Catheter Sets | LJS | 2016-02-05 | 130 |
| K131144 | AMECO SHEATH INTRODUCER | DYB | 2013-08-15 | 114 |
| K131814 | AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER | MSD | 2013-07-26 | 36 |
| K123943 | AMECATH DUAL LUMEN HEMODIALYSIS CATHETER | MSD | 2013-04-02 | 103 |
| K110794 | AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS | FOZ | 2011-12-21 | 274 |
| K110793 | AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS | MPB | 2011-12-16 | 269 |
Recalls
openFDA lists no recalls under a recalling firm named Ameco Medical Industries.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ameco Medical Industries?
FDA lists 6 510(k) clearances under the applicant name “Ameco Medical Industries” (first 2011, latest 2016), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ameco Medical Industries?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ameco Medical Industries is 122 days.
Which FDA product codes appear under Ameco Medical Industries?
The most frequent FDA product codes under this applicant name are MSD (Catheter, Hemodialysis, Implanted, 2); DYB (Introducer, Catheter, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 6 Ameco Medical Industries clearances with predicates and recalls
- Run predicate analysis for product code MSD, Ameco Medical Industries'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.