Best Industries: FDA clearances and approvals
Best Industries has 9 FDA 510(k) clearances (first 1991, latest 1994), across 4 product codes in 1 review panel. Median 510(k) review time: 284 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 |
|---|---|---|---|
| IWJ | System, Applicator, Radionuclide, Manual | 4 | 4 |
| KXK | Source, Brachytherapy, Radionuclide | 3 | 3 |
| IWI | Source, Isotope, Sealed, Gold, Titanium, Platinum | 1 | 1 |
| IWS | Shield, Eye, Radiological | 1 | 1 |
Review panels
- Radiology (9)
Most recent Best Industries 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940121 | IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS | IWJ | 1994-12-30 | 354 |
| K940119 | ROYAL MARSDEN GOLD GRAIN GUN | IWS | 1994-12-30 | 354 |
| K933410 | IMPLANT APPLICATORS, CARTRIDGES/MAGAZINES, IMPLANTERS FOR PERMANENT IMPLANT OF RADIOACTIVE SEEDS/SOURCES | IWJ | 1994-12-30 | 533 |
| K932242 | RADIOACTIVE SAMARIUM 145 SEEDS/SOURCES #2341-2345 | KXK | 1993-07-27 | 81 |
| K930570 | RADIOACTIVE PALLADIUM 103 SEEDS/SOURCES | KXK | 1993-06-04 | 120 |
| K924290 | BEST INDUSTRIES CARTRIDGE & GUN | IWJ | 1993-06-04 | 287 |
| K924261 | RADIOACTIVE CESIUM-131 SEEDS/SOURCES | KXK | 1993-06-04 | 284 |
| K912170 | RADIOACTIVE IODINE-125 SOURCES | IWI | 1991-08-09 | 85 |
| K910862 | VARIOUS TEMPLATE APPLICATORS | IWJ | 1991-04-18 | 48 |
Recalls
openFDA lists no recalls under a recalling firm named Best Industries.
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 Best Industries have?
Best Industries has 9 FDA 510(k) clearances (first 1991, latest 1994), across 4 product codes in 1 review panel.
How long does FDA take to clear Best Industries's 510(k)s?
The median time from FDA receipt to decision across Best Industries's cleared 510(k)s is 284 days.
What devices does Best Industries make?
Its most frequent FDA product codes are IWJ (System, Applicator, Radionuclide, Manual, 4); KXK (Source, Brachytherapy, Radionuclide, 3); IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum, 1).
Has Best Industries had device recalls?
openFDA lists no recalls under a recalling firm name matching Best Industries. Related entities may recall under other names.
Next steps
- See all 9 Best Industries clearances with predicates and recalls
- Run predicate analysis for product code IWJ, Best Industries'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.