Or-Nim Medical , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Or-Nim Medical , Ltd.” (first 2008, latest 2015), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 | 1 | 84 |
| 2014 | 0 | — |
| 2015 | 1 | 275 |
| 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 |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | 3 | 3 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 | 2 |
Review panels
Most recent Or-Nim Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150268 | CerOX | DPW | 2015-11-06 | 275 |
| K131854 | CEROX | DPW | 2013-09-13 | 84 |
| K100875 | CEROX, MODEL 321OF | MUD | 2011-01-25 | 301 |
| K093923 | CEROX MODEL 3210 | MUD | 2010-01-19 | 28 |
| K073407 | PACIFICA | MUD | 2008-02-28 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Or-Nim Medical , Ltd..
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 Or-Nim Medical , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Or-Nim Medical , Ltd.” (first 2008, latest 2015), across 2 product codes in 2 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 Or-Nim Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Or-Nim Medical , Ltd. is 86 days.
Which FDA product codes appear under Or-Nim Medical , Ltd.?
The most frequent FDA product codes under this applicant name are MUD (Oximeter, Tissue Saturation, 3); DPW (Flowmeter, Blood, Cardiovascular, 2).
Next steps
- See all 5 Or-Nim Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MUD, Or-Nim Medical , Ltd.'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.