510(k) · Cleared
ClearedRostam Scented and Unscented Biodegradable Plastic Applicator Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rostam, Ltd. · HEB Tampon, Menstrual, Unscented
Cleared on Nov 10, 2010 as substantially equivalent to K042773 (Rostam, Ltd., 2004) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Nov 10, 2010
- Review
- 76 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K042773 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK042773 Rostam Scented and Unscented Plastic Applicator TamponsRostam, Ltd. · 2004
- This deviceK102445 Rostam Scented and Unscented Biodegradable Plastic Applicator TamponsRostam, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042773 | Rostam Scented and Unscented Plastic Applicator Tampons | Rostam, Ltd. | 2004 | — |
| 0 (this device) | K102445 | Rostam Scented and Unscented Biodegradable Plastic Applicator Tampons | Rostam, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HEB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HEB device
- #1 K251033 Unscented menstrual long applicator tampon…score 14.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042773 | Rostam Scented and Unscented Plastic Applicator TamponsSummary page 1…5460 and 21 CFR 884.5470. The predicate tampons have been marketed under K 042773 anid 1K062001. RegulationName: (Unscented menstrual tampon & Scented menstrual tampon), regulation number (21i C… | 2004 |
| * | K062001 | Rostam Scented and Unscented Plastic Applicator TamponsSummary page 1…884.5470. The predicate tampons have been marketed under K 042773 anid 1K062001. RegulationName: (Unscented menstrual tampon & Scented menstrual tampon), regulation number (21i CFR 884.5470 &… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K042773.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HEB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HEB
82in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEB
29in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEB
452in 2025
MAUDE reports naming product code HEB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 38 |
| 2008 | 1 | — | 0 | 31 |
| 2009 | 7 | 136 | 0 | 30 |
| 2010 | 3 | 76 | 1 | 138 |
| 2011 | 3 | 28 | 1 | 291 |
| 2012 | 3 | 114 | 0 | 416 |
| 2013 | 2 | — | 0 | 259 |
| 2014 | 4 | 173 | 0 | 167 |
| 2015 | 5 | 114 | 0 | 132 |
| 2016 | 1 | — | 0 | 101 |
| 2017 | 2 | — | 0 | 194 |
| 2018 | 5 | 140 | 4 | 363 |
| 2019 | 7 | 182 | 0 | 3,034 |
| 2020 | 2 | — | 0 | 1,714 |
| 2021 | 6 | 60 | 0 | 1,403 |
| 2022 | 3 | 81 | 0 | 1,055 |
| 2023 | 5 | 109 | 0 | 702 |
| 2024 | 2 | — | 0 | 534 |
| 2025 | 6 | 82 | 29 | 452 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Rosiamn Scented anid Unscented Biodegradable PRastic Applicator Tarmpons are inserted into the vagina and used to absoab menstrual orocther vaginal discharge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102445 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102445: Rostam Scented and Unscented Biodegradable Plastic Applicator Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102445
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026