A Company, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “A Company, Inc.” (first 1982, latest 1990), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| ECI | Band, Elastic, Orthodontic | 5 | 5 |
| DZC | Wire, Orthodontic | 2 | 2 |
| EJF | Bracket, Metal, Orthodontic | 2 | 2 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 1 | 1 |
| DZB | Headgear, Extraoral, Orthodontic | 1 | 1 |
| DZM | Needle, Dental | 1 | 1 |
| ECQ | Aligner, Bracket, Orthodontic | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
Review panels
- Dental (14)
Most recent A Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | EKS | 1990-05-31 | 153 |
| K852800 | A-COMPANY SELF-LIGATING APPLIANCE | EJF | 1985-07-31 | 30 |
| K852670 | A-COMPANY ESPREE SAFETY HEADGEAR | DZB | 1985-07-31 | 37 |
| K852600 | A-COMPANY ELASTOMERIC CHAIN DISPENSER | ECI | 1985-07-31 | 42 |
| K852599 | A-COMPANY ELASTOMERIC TUBING | ECI | 1985-07-31 | 42 |
| K852598 | A-COMPANY SEPARATING ELASTICS | ECI | 1985-07-31 | 42 |
| K852597 | A-COMPANY ELASTIC ROTATION WEDGES | ECI | 1985-07-31 | 42 |
| K852596 | A-COMPANY ELASTIC LIGATURE RINGS | ECI | 1985-07-31 | 42 |
| K851878 | A COMPANY BRASS SEPARATING RINGS | DZC | 1985-06-05 | 37 |
| K851454 | A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS | ECQ | 1985-04-29 | 18 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named A Company, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under A Company, Inc.?
FDA lists 14 510(k) clearances under the applicant name “A Company, Inc.” (first 1982, latest 1990), across 8 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 A Company, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A Company, Inc. is 42 days.
Which FDA product codes appear under A Company, Inc.?
The most frequent FDA product codes under this applicant name are ECI (Band, Elastic, Orthodontic, 5); DZC (Wire, Orthodontic, 2); EJF (Bracket, Metal, Orthodontic, 2).
Next steps
- See all 14 A Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ECI, A Company, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.