Shargh Pharmaceutical Co., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shargh Pharmaceutical Co., Inc.” (first 1990, latest 2002), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 343 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Review panels
Most recent Shargh Pharmaceutical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013384 | SHARGHP A.V. FISTULA NEEDLE SET | FIE | 2002-01-07 | 87 |
| K895980 | SHARGHP INSULIN SYRINGES | FMF | 1990-09-07 | 343 |
| K895812 | SHARGHP INTRAVENOUS CATHETER | FOZ | 1990-09-07 | 343 |
| K895811 | SHARGHP HYPODERMIC NEEDLE | FMI | 1990-09-07 | 343 |
| K895810 | SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE | FMF | 1990-09-07 | 343 |
Recalls
openFDA lists no recalls under a recalling firm named Shargh Pharmaceutical Co., 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 Shargh Pharmaceutical Co., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Shargh Pharmaceutical Co., Inc.” (first 1990, latest 2002), across 4 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 Shargh Pharmaceutical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shargh Pharmaceutical Co., Inc. is 343 days.
Which FDA product codes appear under Shargh Pharmaceutical Co., Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 2); FIE (Needle, Fistula, 1); FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 5 Shargh Pharmaceutical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Shargh Pharmaceutical Co., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.