Implant Sciences Corp.: FDA clearances and approvals
Implant Sciences Corp. has 6 FDA 510(k) clearances (first 1999, latest 2007), across 1 product code in 1 review panel. Median 510(k) review time: 85 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 6 | 6 |
Review panels
- Radiology (6)
Most recent Implant Sciences Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070468 | IMPLANT SCIENCES CORP. MODEL HDR 4454 | KXK | 2007-03-23 | 35 |
| K042864 | IMPLANT SCIENCES CORP, MODEL HDR-4140 | KXK | 2005-01-06 | 80 |
| K023073 | SEED LINK | KXK | 2003-04-07 | 203 |
| K023242 | I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE | KXK | 2002-12-04 | 65 |
| K994317 | I-PLANT, MODEL 3500 | KXK | 2000-03-21 | 90 |
| K990193 | IODINE BRACHYTHERAPY SEEDS, MODEL 3000 | KXK | 1999-05-20 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Implant Sciences Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances does Implant Sciences Corp. have?
Implant Sciences Corp. has 6 FDA 510(k) clearances (first 1999, latest 2007), across 1 product code in 1 review panel.
How long does FDA take to clear Implant Sciences Corp.'s 510(k)s?
The median time from FDA receipt to decision across Implant Sciences Corp.'s cleared 510(k)s is 85 days.
What devices does Implant Sciences Corp. make?
Its most frequent FDA product codes are KXK (Source, Brachytherapy, Radionuclide, 6).
Has Implant Sciences Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Implant Sciences Corp. Related entities may recall under other names.
Next steps
- See all 6 Implant Sciences Corp. clearances with predicates and recalls
- Run predicate analysis for product code KXK, Implant Sciences Corp.'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.