Acu-Med, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Acu-Med, Inc.” (first 1991, latest 1996), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 88 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| MQX | Needle, Acupuncture, Single Use | 1 | 1 |
Review panels
- Orthopedic (4)
- General Hospital (1)
Most recent Acu-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960769 | ACUPUNCTURE NEEDLE PACK | MQX | 1996-07-10 | 135 |
| K960651 | CERCLAGE WIRE CRIMP BLOCK | JDQ | 1996-05-03 | 78 |
| K952534 | TENTATIVELY POLARUS EX ROD | HSB | 1995-07-13 | 42 |
| K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM | JDQ | 1992-06-26 | 88 |
| K910193 | HUENE FIXATION SCREW | HWC | 1991-08-23 | 219 |
Recalls
openFDA lists no recalls under a recalling firm named Acu-Med, 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 Acu-Med, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Acu-Med, Inc.” (first 1991, latest 1996), across 4 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 Acu-Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acu-Med, Inc. is 88 days.
Which FDA product codes appear under Acu-Med, Inc.?
The most frequent FDA product codes under this applicant name are JDQ (Cerclage, Fixation, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 5 Acu-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDQ, Acu-Med, 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, 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.