Rostam , Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Rostam , Ltd.” (first 1997, latest 2010), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 7 | 7 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 2 | 2 |
Review panels
Most recent Rostam , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102445 | ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS | HEB | 2010-11-10 | 76 |
| K090071 | ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS | HEB | 2009-05-28 | 136 |
| K062001 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | HEB | 2006-12-07 | 146 |
| K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | HIL | 2004-11-23 | 49 |
| K030474 | PH BUFFERING PLASTIC APPLICATOR TAMPON | HEB | 2004-05-28 | 471 |
| K032080 | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS | HIL | 2003-08-14 | 38 |
| K020535 | INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | HEB | 2002-05-09 | 79 |
| K001641 | TAMPONS | HEB | 2000-08-03 | 65 |
| K965064 | ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON | HEB | 1997-02-20 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Rostam , 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 Rostam , Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Rostam , Ltd.” (first 1997, latest 2010), across 2 product codes 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 Rostam , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rostam , Ltd. is 76 days.
Which FDA product codes appear under Rostam , Ltd.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 7); HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 2).
Next steps
- See all 9 Rostam , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HEB, Rostam , 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.