Izi Medical Products, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Izi Medical Products, LLC” (first 2010, latest 2019), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 136 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 | 259 |
| 2015 | 2 | 181 |
| 2016 | 1 | 96 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 113 |
| 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 Izi Medical Products, LLC took a median 113 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 3 | 3 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Neurology (3)
- Radiology (2)
- Orthopedic (1)
Most recent Izi Medical Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191012 | Navigated Pedicle Access Kit | OLO | 2019-08-07 | 113 |
| K162265 | CushionCast Moldable Cushions | IYE | 2016-11-15 | 96 |
| K143241 | MDT Navigable Brain Biopsy Cannula | HAW | 2015-04-13 | 152 |
| K142344 | DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System | HAW | 2015-03-20 | 210 |
| K140705 | NAVIGABLE BRAIN BIOPSY CANNULA SET | HAW | 2014-12-05 | 259 |
| K101373 | EMBRACE | IZH | 2010-09-15 | 121 |
Recalls
openFDA lists no recalls under a recalling firm named Izi Medical Products, 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 Izi Medical Products, LLC?
FDA lists 6 510(k) clearances under the applicant name “Izi Medical Products, LLC” (first 2010, latest 2019), across 4 product codes in 3 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 Izi Medical Products, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Izi Medical Products, LLC is 136 days.
Which FDA product codes appear under Izi Medical Products, LLC?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 3); IYE (Accelerator, Linear, Medical, 1); IZH (System, X-Ray, Mammographic, 1).
Next steps
- See all 6 Izi Medical Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code HAW, Izi Medical Products, 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, 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.