Onefit Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Onefit Medical” (first 2014, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 77 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 |
|---|---|---|
| 2014 | 1 | 77 |
| 2015 | 0 | — |
| 2016 | 3 | 52 |
| 2017 | 0 | — |
| 2018 | 1 | 179 |
| 2019 | 0 | — |
| 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 Onefit Medical took a median 179 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
Review panels
- Radiology (5)
Most recent Onefit Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173390 | hipEOS | LLZ | 2018-04-27 | 179 |
| K161828 | kneeEOS | LLZ | 2016-10-03 | 90 |
| K161479 | hipEOS | LLZ | 2016-06-28 | 28 |
| K160407 | spineEOS | LLZ | 2016-04-08 | 52 |
| K142671 | ONEFIT HIP PLANNER | LLZ | 2014-12-05 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Onefit Medical.
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 Onefit Medical?
FDA lists 5 510(k) clearances under the applicant name “Onefit Medical” (first 2014, latest 2018), 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 Onefit Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Onefit Medical is 77 days.
Which FDA product codes appear under Onefit Medical?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5).
Next steps
- See all 5 Onefit Medical clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Onefit Medical'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.