Acmi Corporation: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Acmi Corporation” (first 2002, latest 2006), across 13 product codes in 3 review panels. Median 510(k) review time under this name: 72 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Olympus, based on public ownership records.
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 |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 2 | 2 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| EYB | Catheter, Ureteral, Gastro-Urology | 1 | 1 |
| FAS | Electrode, Electrosurgical, Active, Urological | 1 | 1 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FBP | Telescope, Rigid, Endoscopic | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HHI | System, Abortion, Vacuum | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Acmi Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061975 | PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK | GEI | 2006-08-10 | 28 |
| K060752 | ACMI DUR-HL LASER SYSTEMS | GEX | 2006-05-25 | 65 |
| K060269 | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM | FBN | 2006-03-31 | 58 |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | KNY | 2005-09-02 | 78 |
| K052044 | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL | FGB | 2005-08-16 | 19 |
| K043581 | DUAL LUMEN CATHETER | EYB | 2005-03-03 | 65 |
| K042069 | INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM | GCJ | 2004-11-01 | 91 |
| K042225 | ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 | FAJ | 2004-09-10 | 24 |
| K031758 | ACMI M4 TELESCOPES | FBP | 2003-09-02 | 88 |
| K030960 | ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE | FAJ | 2003-07-16 | 111 |
6 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-04-30.
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 Acmi Corporation?
FDA lists 16 510(k) clearances under the applicant name “Acmi Corporation” (first 2002, latest 2006), across 13 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 Acmi Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acmi Corporation is 72 days.
Which FDA product codes appear under Acmi Corporation?
The most frequent FDA product codes under this applicant name are FAJ (Cystoscope And Accessories, Flexible/Rigid, 2); FGB (Ureteroscope And Accessories, Flexible/Rigid, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 16 Acmi Corporation clearances with predicates and recalls
- Run predicate analysis for product code FAJ, Acmi Corporation'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.