Acme-Monaco Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Acme-Monaco Corp.” (first 1988, latest 2012), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 188 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 | 1 | 268 |
| 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 2 | 2 |
| EJF | Bracket, Metal, Orthodontic | 2 | 2 |
| KOD | Catheter, Urological | 1 | 1 |
Review panels
- Cardiovascular (2)
- Dental (2)
- Gastroenterology and Urology (1)
Most recent Acme-Monaco Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113162 | SLIDEWIRETM(TRADEMARK PENDING) | DQX | 2012-07-20 | 268 |
| K920884 | GUIDEWIRES, VARIOUS TYPES | DQX | 1992-08-19 | 230 |
| K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) | EJF | 1990-04-09 | 188 |
| K895483 | ACME COATED ORTHODONTIC ARCHWIRE | EJF | 1990-01-29 | 140 |
| K883763 | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH | KOD | 1988-11-18 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Acme-Monaco Corp..
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 Acme-Monaco Corp.?
FDA lists 5 510(k) clearances under the applicant name “Acme-Monaco Corp.” (first 1988, latest 2012), across 3 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 Acme-Monaco Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acme-Monaco Corp. is 188 days.
Which FDA product codes appear under Acme-Monaco Corp.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 2); EJF (Bracket, Metal, Orthodontic, 2); KOD (Catheter, Urological, 1).
Next steps
- See all 5 Acme-Monaco Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Acme-Monaco 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.