Alto Development Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Alto Development Corp.” (first 1982, latest 1996), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| FZQ | Clip, Removable (Skin) | 1 | 1 |
| GAO | Suture, Nonabsorbable | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
Most recent Alto Development Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964621 | A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON | GEI | 1996-12-20 | 32 |
| K932513 | LABELING FOR MYO/WIRE II STERNOTOMY SUTURES | GAO | 1994-01-07 | 227 |
| K931537 | A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT | GEI | 1993-09-07 | 162 |
| K930528 | A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS | GEI | 1993-05-17 | 104 |
| K914193 | A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT | GEI | 1992-10-05 | 383 |
| K915300 | A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES | GEI | 1992-02-18 | 89 |
| K884783 | RANEY CLIP | FZQ | 1988-11-30 | 15 |
| K881413 | ELECTRO-CAUTERY SUCTION TUBE | GEI | 1988-04-21 | 17 |
| K831867 | PRESSURE MONITORING IV BOTTLE CAP | DRS | 1983-08-12 | 63 |
| K821518 | MYO/CLIP | LDF | 1982-07-08 | 48 |
Recalls
7 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-09-10.
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 Alto Development Corp.?
FDA lists 10 510(k) clearances under the applicant name “Alto Development Corp.” (first 1982, latest 1996), across 5 product codes in 2 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 Alto Development Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alto Development Corp. is 76 days.
Which FDA product codes appear under Alto Development Corp.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); DRS (Transducer, Blood-Pressure, Extravascular, 1); FZQ (Clip, Removable (Skin), 1).
Next steps
- See all 10 Alto Development Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Alto Development Corp.'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.