Medcad: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Medcad” (first 2020, latest 2026), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 265 days. Since 2017 the median was 265 days, against 196 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 |
|---|---|---|
| 2020 | 1 | 434 |
| 2021 | 1 | 443 |
| 2022 | 1 | 199 |
| 2023 | 3 | 222 |
| 2024 | 0 | — |
| 2025 | 2 | 210 |
| 2026 | 1 | 269 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medcad took a median 265 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 4 | 4 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 | 2 |
| JEY | Plate, Bone | 2 | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
Review panels
- Dental (4)
- Orthopedic (4)
- Neurology (1)
Most recent Medcad 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252064 | MedCAD® AccuStride System | PBF | 2026-03-27 | 269 |
| K251709 | MedCAD® AccuStride System | PBF | 2025-11-04 | 154 |
| K241811 | MedCAD® AccuStride System | PBF | 2025-03-13 | 265 |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | JEY | 2023-09-26 | 222 |
| K223421 | MedCAD AccuPlan Orthopedics System | PBF | 2023-09-20 | 314 |
| K223024 | MedCAD AccuPlan System | DZJ | 2023-03-07 | 159 |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | GXN | 2022-08-26 | 199 |
| K193280 | MedCAD® AccuPlate® Patient-Specific Plate | JEY | 2021-02-12 | 443 |
| K192282 | MedCAD® AccuPlan® System | DZJ | 2020-10-29 | 434 |
Recalls
openFDA lists no recalls under a recalling firm named Medcad.
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 Medcad?
FDA lists 9 510(k) clearances under the applicant name “Medcad” (first 2020, latest 2026), across 4 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 Medcad?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcad is 265 days. Since 2017: 265 days, versus 196 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medcad?
The most frequent FDA product codes under this applicant name are PBF (Orthopaedic Surgical Planning And Instrument Guides, 4); DZJ (Driver, Wire, And Bone Drill, Manual, 2); JEY (Plate, Bone, 2).
Next steps
- See all 9 Medcad clearances with predicates and recalls
- Run predicate analysis for product code PBF, Medcad'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.