Infinium Medical: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Infinium Medical” (first 2010, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 162 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 | 1 | 218 |
| 2015 | 1 | 177 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 184 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Infinium Medical took a median 184 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 217 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 7 | 7 |
Review panels
- Cardiovascular (7)
Most recent Infinium Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2) | MWI | 2026-08-14 | 184 |
| K142244 | CLEO PATIENT MONITOR | MWI | 2015-02-06 | 177 |
| K132229 | OMNI PATENT MONITORS | MWI | 2014-02-21 | 218 |
| K112329 | OMNI PATIENT MONITOR | MWI | 2011-09-08 | 27 |
| K103737 | OMNI II PATIENT MONITOR | MWI | 2011-06-02 | 162 |
| K103268 | OMNI EXPRESS | MWI | 2010-11-23 | 19 |
| K101052 | OMNI III PATIENT MONITOR | MWI | 2010-08-11 | 118 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-05-31.
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 Infinium Medical?
FDA lists 7 510(k) clearances under the applicant name “Infinium Medical” (first 2010, latest 2026), 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 Infinium Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Infinium Medical is 162 days.
Which FDA product codes appear under Infinium Medical?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 7).
Next steps
- See all 7 Infinium Medical clearances with predicates and recalls
- Run predicate analysis for product code MWI, Infinium 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.