Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rostam , Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
471 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102445 | ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATO | Rostam , Ltd. | 2010-11-10 | 76 | 0 |
| K090071 | ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATO | Rostam , Ltd. | 2009-05-28 | 136 | 0 |
| K062001 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2006-12-07 | 146 | 0 |
| K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2004-11-23 | 49 | 0 |
| K030474 | PH BUFFERING PLASTIC APPLICATOR TAMPON | Rostam , Ltd. | 2004-05-28 | 471 | 0 |
| K032080 | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2003-08-14 | 38 | 0 |
| K020535 | INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | Rostam , Ltd. | 2002-05-09 | 79 | 0 |
| K001641 | TAMPONS | Rostam , Ltd. | 2000-08-03 | 65 | 0 |
| K965064 | ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON | Rostam , Ltd. | 1997-02-20 | 64 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda