Iradimed Corporation: FDA clearances and approvals
Iradimed Corporation has 7 FDA 510(k) clearances (first 2005, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time: 96 days. Since 2017 its median was 177 days, against 220 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Iradimed Corporation. It files with the SEC as IRADIMED CORP (IRMD).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 751 |
| 2017 | 1 | 96 |
| 2018 | 1 | 59 |
| 2019 | 1 | 357 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 258 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Iradimed Corporation's cleared 510(k)s took a median 177 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 220 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 4 | 4 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 3 | 3 |
Review panels
- General Hospital (4)
- Cardiovascular (3)
Most recent Iradimed Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242752 | MRidium 3870 MRI Infusion Pump System (3870) | FRN | 2025-05-28 | 258 |
| K180903 | 3880 MRI Patient Monitoring System | MWI | 2019-03-29 | 357 |
| K182900 | 3880 MRI Patient Monitoring System | MWI | 2018-12-14 | 59 |
| K172200 | 3880 MRI Patient Monitoring System | MWI | 2017-10-25 | 96 |
| K143369 | MRidium 3860+ MRI infusion Pump/ Monitoring System | FRN | 2016-12-15 | 751 |
| K090087 | MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM | FRN | 2009-04-07 | 84 |
| K050301 | MRIDIUM 3850 MRI PUMP SYSTEM | FRN | 2005-03-24 | 44 |
Recalls
3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2023-02-24.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
IRADIMED CORP (IRMD): EDGAR filings, CIK 1325618. Matched by exact company name.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Iradimed Corporation's product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Iradimed Corporation have?
Iradimed Corporation has 7 FDA 510(k) clearances (first 2005, latest 2025), across 2 product codes in 2 review panels.
How long does FDA take to clear Iradimed Corporation's 510(k)s?
The median time from FDA receipt to decision across Iradimed Corporation's cleared 510(k)s is 96 days. Since 2017: 177 days, versus 220 days for all cleared 510(k)s in the same product codes.
What devices does Iradimed Corporation make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 4); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 3).
Has Iradimed Corporation had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Iradimed Corporation; the most recent began 2023-02-24. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Iradimed Corporation clearances with predicates and recalls
- Run predicate analysis for product code FRN, Iradimed Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.