Aptis Medical, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Aptis Medical, LLC” (first 2005, latest 2019), across 1 product code in 1 review panel. Median 510(k) review time under this name: 56 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 | 1 | 203 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 56 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aptis Medical, LLC took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 56 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 5 | 5 |
Review panels
- Orthopedic (5)
Most recent Aptis Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | KXE | 2019-05-03 | 56 |
| K142569 | Aptis Medical Distal Radio Ulnar Joint Implant | KXE | 2015-04-03 | 203 |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | KXE | 2008-10-24 | 28 |
| K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | KXE | 2005-12-07 | 30 |
| K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | KXE | 2005-01-26 | 335 |
Recalls
openFDA lists no recalls under a recalling firm named Aptis Medical, LLC.
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 Aptis Medical, LLC?
FDA lists 5 510(k) clearances under the applicant name “Aptis Medical, LLC” (first 2005, latest 2019), across 1 product code 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 Aptis Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aptis Medical, LLC is 56 days.
Which FDA product codes appear under Aptis Medical, LLC?
The most frequent FDA product codes under this applicant name are KXE (Prosthesis, Wrist, Hemi-, Ulnar, 5).
Next steps
- See all 5 Aptis Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code KXE, Aptis Medical, 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.