Acumed, LLC: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Acumed, LLC” (first 2003, latest 2025), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 94 days, against 92 days for all cleared 510(k)s in the same product codes. 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 | 2 | 100 |
| 2013 | 6 | 96 |
| 2014 | 4 | 78 |
| 2015 | 4 | 98 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 125 |
| 2022 | 2 | 172 |
| 2023 | 1 | 84 |
| 2024 | 1 | 206 |
| 2025 | 4 | 56 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acumed, LLC took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 20 | 20 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| HTN | Washer, Bolt Nut | 4 | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 3 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 | 1 |
Review panels
- Orthopedic (38)
Most recent Acumed, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | HRS | 2025-08-21 | 23 |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | HRS | 2025-07-14 | 94 |
| K251296 | The Acumed Wrist Fixation System | HRS | 2025-06-18 | 54 |
| K243624 | Acu-Sinch Knotless Mini | HTN | 2025-01-23 | 59 |
| K233311 | Acumed Wrist Plating System | HRS | 2024-04-22 | 206 |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | HWC | 2023-06-09 | 84 |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | HWC | 2022-12-29 | 234 |
| K212990 | Acumed Ankle Syndesmosis Repair System | HTN | 2022-01-07 | 109 |
| K210750 | Acumed Clavicle Hook Plating System | HRS | 2021-07-15 | 125 |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | HRS | 2015-10-30 | 113 |
28 earlier clearances. See the full list in Caduvo.
Recalls
51 product recalls in 22 recall events; 9 initiated in the last five years. Most recent: 2026-05-28.
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 Instruments Corp. (8 510(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, LLC?
FDA lists 38 510(k) clearances under the applicant name “Acumed, LLC” (first 2003, latest 2025), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acumed, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acumed, LLC is 88 days. Since 2017: 94 days, versus 92 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Acumed, LLC?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 20); HWC (Screw, Fixation, Bone, 5); HTN (Washer, Bolt Nut, 4).
Next steps
- See all 38 Acumed, LLC clearances with predicates and recalls
- Run predicate analysis for product code HRS, Acumed, LLC'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.