Pharmaceutical Innovations, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pharmaceutical Innovations, Inc.” (first 1996, latest 2018), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 434 days. Since 2017 the median was 434 days, against 236 days for all cleared 510(k)s in the same product codes. 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 | 4 | 434 |
| 2019 | 0 | — |
| 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 Pharmaceutical Innovations, Inc. took a median 434 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | 4 | 4 |
| KMJ | Lubricant, Patient | 1 | 1 |
Review panels
- Radiology (4)
- General Hospital (1)
Most recent Pharmaceutical Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163027 | Ultra/Phonic Free Conductivity Gel | MUI | 2018-01-09 | 435 |
| K163026 | Ultra/Phonic Scanning Gel | MUI | 2018-01-09 | 435 |
| K163024 | Ultra/Phonic Conductivity Gel | MUI | 2018-01-08 | 434 |
| K163023 | Other-Sonic Transmission Gel | MUI | 2018-01-08 | 434 |
| K961222 | EVRON GEL | KMJ | 1996-06-26 | 90 |
Recalls
8 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2020-08-13.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pharmaceutical Development Systems (1 510(k)s)
- Pharmaceutical Infusion Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pharmaceutical Innovations, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Pharmaceutical Innovations, Inc.” (first 1996, latest 2018), across 2 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 Pharmaceutical Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharmaceutical Innovations, Inc. is 434 days. Since 2017: 434 days, versus 236 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Pharmaceutical Innovations, Inc.?
The most frequent FDA product codes under this applicant name are MUI (Media, Coupling, Ultrasound, 4); KMJ (Lubricant, Patient, 1).
Next steps
- See all 5 Pharmaceutical Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUI, Pharmaceutical Innovations, 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.