Acumed Instruments Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Acumed Instruments Corp.” (first 1979, latest 1986), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 26 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GBQ | Catheter, Continuous Irrigation | 1 | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Acumed Instruments Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863627 | MICRO SURGICAL DRILL SYSTEM | — | 1986-10-02 | 15 |
| K853660 | MICRO SURGICAL DRILL SYSTEM | — | 1985-09-24 | 21 |
| K853659 | POWERED IRRIGATION FOR MICRO SURGICAL DRILL | — | 1985-09-24 | 21 |
| K853658 | BURS FOR MICRO SURGICAL DRILL SYSTEM | GFF | 1985-09-24 | 21 |
| K791891 | ACU-MED RED MISER HEMOTHORAX BLOOD COLL. | CAC | 1979-12-05 | 71 |
| K791399 | ACU-ALERT | — | 1979-10-11 | 87 |
| K791400 | GASTRIC LAVAGE KIT-DISPOSABLE | GBQ | 1979-08-16 | 31 |
| K790901 | I.V. TUBING ORGANIZER | FPA | 1979-06-27 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Acumed Instruments 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Acumed, LLC (38 510(k)s)
- Acumed Medical , Ltd. (1 510(k)s)
- Acumed Medical Supplies , Ltd. (1 510(k)s)
- Acumed Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acumed Instruments Corp.?
FDA lists 8 510(k) clearances under the applicant name “Acumed Instruments Corp.” (first 1979, latest 1986), 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 Acumed Instruments Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acumed Instruments Corp. is 26 days.
Which FDA product codes appear under Acumed Instruments Corp.?
The most frequent FDA product codes under this applicant name are CAC (Apparatus, Autotransfusion, 1); FPA (Set, Administration, Intravascular, 1); GBQ (Catheter, Continuous Irrigation, 1).
Next steps
- See all 8 Acumed Instruments Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAC, Acumed Instruments 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.