Suru Chemicals & Pharmaceuticals, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Suru Chemicals & Pharmaceuticals, Ltd.” (first 1978, latest 1981), across 1 product code in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 8 | 8 |
Review panels
- General Hospital (8)
Most recent Suru Chemicals & Pharmaceuticals, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811006 | SOLUTION ADMINISTRATION SET | FPA | 1981-06-02 | 49 |
| K802170 | SURU BLOOD COLLECTION SET | FPA | 1981-04-06 | 210 |
| K802169 | SURU INFUSION SET TYPE J | FPA | 1981-04-06 | 210 |
| K780658 | STERILE BLOOD ADMINISTRATION SET | FPA | 1978-07-19 | 90 |
| K780657 | STERILE BLOOD COLLECTION SET | FPA | 1978-07-19 | 90 |
| K780656 | STERILE INFUSION SET TYPE J | FPA | 1978-07-19 | 90 |
| K780655 | STERILE INFUSION SET TYPE S | FPA | 1978-07-19 | 90 |
| K772008 | SCALP VEIN SETS | FPA | 1978-01-03 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Suru Chemicals & Pharmaceuticals, Ltd..
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 Suru Chemicals & Pharmaceuticals, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Suru Chemicals & Pharmaceuticals, Ltd.” (first 1978, latest 1981), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Suru Chemicals & Pharmaceuticals, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Suru Chemicals & Pharmaceuticals, Ltd. is 90 days.
Which FDA product codes appear under Suru Chemicals & Pharmaceuticals, Ltd.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 8).
Next steps
- See all 8 Suru Chemicals & Pharmaceuticals, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Suru Chemicals & Pharmaceuticals, Ltd.'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.