Acu Med, Inc.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under 2 spellings of the applicant name “Acu Med, Inc.” (first 1990, latest 2002), across 18 product codes in 3 review panels. Median 510(k) review time under this name: 140 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 9 | 9 |
| HWC | Screw, Fixation, Bone | 9 | 9 |
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HTN | Washer, Bolt Nut | 4 | 4 |
| JDQ | Cerclage, Fixation | 3 | 3 |
| JEC | Component, Traction, Invasive | 3 | 3 |
| HRX | Arthroscope | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
Plus 8 more product codes.
Review panels
Most recent Acu Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021321 | WRIST FUSION PLATE | HRS | 2002-07-17 | 83 |
| K013616 | POLARUS CAP SCREW | HSB | 2001-12-19 | 44 |
| K012655 | CONGRUENT BONE PLATE SYSTEM | HRS | 2001-11-07 | 86 |
| K992525 | ACUMED MODULAR SHOULDER SYSTEM | HSD | 2000-02-04 | 191 |
| K993657 | ACUMED SUTURE ANCHOR | MBI | 2000-01-13 | 77 |
| K980103 | ACUMED SUTURE ANCHOR | MBI | 1998-03-16 | 63 |
| K965028 | ACUMED SUTURE WASHER | HTN | 1997-03-17 | 90 |
| K965029 | STABLELOC II EXTERNAL FIXATOR | JEC | 1997-02-19 | 64 |
| K964500 | ACUMED TENSION BAND PIN | HTY | 1996-12-09 | 31 |
| K963026 | TBD | HSB | 1996-10-28 | 84 |
38 earlier clearances. See the full list in Caduvo.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Acu Med, Inc. (43)
- Acu-Med, Inc. (5)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acu Med, Inc.?
FDA lists 48 510(k) clearances under 2 spellings of the applicant name “Acu Med, Inc.” (first 1990, latest 2002), across 18 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 Acu Med, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acu Med, Inc. is 140 days.
Which FDA product codes appear under Acu Med, Inc.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 9); HWC (Screw, Fixation, Bone, 9); HRS (Plate, Fixation, Bone, 4).
Next steps
- See all 48 Acu Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, 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 (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.