Sporicidin Intl.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Sporicidin Intl.” (first 1983, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 150 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 | 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 |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | 5 | 5 |
| MED | Sterilant, Medical Devices | 2 | 2 |
| LIF | Dialyzer Reprocessing System | 1 | 1 |
Review panels
Most recent Sporicidin Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003087 | MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION | MED | 2000-11-07 | 41 |
| K983194 | SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) | MED | 1999-03-05 | 175 |
| K926013 | SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI | LRJ | 1993-02-12 | 80 |
| K922262 | SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT | LRJ | 1992-09-15 | 126 |
| K904581 | SPORICIDIN BRAND DISINFECTANT SOLUTION | LRJ | 1992-05-18 | 587 |
| K904580 | SPORICIDIN BRAND DISINFECTANT SPRAY | LRJ | 1992-05-18 | 587 |
| K904579 | SPORICIDIN BRAND DISINFECTANT TOWELETTES | LRJ | 1992-05-18 | 587 |
| K830722 | SPORIDIDIN-D COLD STERILIZING/SOLUTION | LIF | 1983-06-30 | 114 |
Recalls
openFDA lists no recalls under a recalling firm named Sporicidin Intl..
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 Sporicidin Intl.?
FDA lists 8 510(k) clearances under the applicant name “Sporicidin Intl.” (first 1983, latest 2000), across 3 product codes in 2 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 Sporicidin Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sporicidin Intl. is 150 days.
Which FDA product codes appear under Sporicidin Intl.?
The most frequent FDA product codes under this applicant name are LRJ (Disinfectant, Medical Devices, 5); MED (Sterilant, Medical Devices, 2); LIF (Dialyzer Reprocessing System, 1).
Next steps
- See all 8 Sporicidin Intl. clearances with predicates and recalls
- Run predicate analysis for product code LRJ, Sporicidin Intl.'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.