Puricore, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Puricore, Inc.” (first 2006, latest 2015), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 135 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 | 2 | 126 |
| 2014 | 1 | 283 |
| 2015 | 1 | 308 |
| 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 8 | 8 |
| KJJ | Cleanser, Root Canal | 1 | 1 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
Most recent Puricore, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141863 | PURICORE WOUND HYDROGEL SPRAY DRESSING | FRO | 2015-05-14 | 308 |
| K131848 | VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) | FRO | 2014-03-31 | 283 |
| K123072 | VASHE WOUND THERAPY SOLUTION | FRO | 2013-02-14 | 136 |
| K123071 | VASHE SKIN AND WOUND HYDROGEL | FRO | 2013-01-24 | 115 |
| K100918 | VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014 | FRO | 2010-08-09 | 129 |
| K093697 | VASHE WOUND THERAPY SOLUTION | FRO | 2010-04-13 | 134 |
| K093155 | VASHE WOUND CLEANSING SYSTEM | FRO | 2010-03-01 | 146 |
| K092232 | MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014 | FRO | 2009-08-19 | 27 |
| K063159 | STERILOX LIQUID CHEMICAL STERILANT SYSTEM | MED | 2007-04-02 | 167 |
| K061689 | AQUATINE EC ENDODONTIC CLEANSER | KJJ | 2006-08-24 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Puricore, Inc..
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 Puricore, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Puricore, Inc.” (first 2006, latest 2015), across 3 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 Puricore, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Puricore, Inc. is 135 days.
Which FDA product codes appear under Puricore, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 8); KJJ (Cleanser, Root Canal, 1); MED (Sterilant, Medical Devices, 1).
Next steps
- See all 10 Puricore, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Puricore, Inc.'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.