510(k) · Cleared
ClearedRostam LTD. Fragranced or Unfragranced New 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 May 28, 2009 after a 136-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- May 28, 2009
- Review
- 136 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK090071 Rostam LTD. Fragranced or Unfragranced New Plastic Applicator TamponsRostam, Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK173225 Interlude and private label Unscented 3-piece compact applicator…Albaad Fem · 2018
- Descendant · 2 generations on · 0 of its ownK230419 Sequel Tampon with Plastic ApplicatorTampro, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK191431 Interlude Rolled Tampons in Plastic ApplicatorAlbaad Fem · 2019
Most influential descendants
Showing 3 of 3 · See all- K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem · 2018 · cites it directly2descendants
- K230419Sequel Tampon with Plastic ApplicatorTampro, Inc. · 2023 · 2 generations on0descendants
- K191431Interlude Rolled Tampons in Plastic ApplicatorAlbaad Fem · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090071 | Rostam LTD. Fragranced or Unfragranced New Plastic Applicator Tampons | Rostam, Ltd. | 2009 | — |
| +1 | K173225 | Interlude and private label Unscented 3-piece compact applicator tampon | Albaad Fem | 2018 | — |
| +2 | K230419 | Sequel Tampon with Plastic Applicator | Tampro, Inc. | 2023 | — |
| +2 | K191431 | Interlude Rolled Tampons in Plastic Applicator | Albaad Fem | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | — | Tampax Compak Pearl Scented and unscented Tampons with plastic applicators Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173225 | Interlude and private label Unscented 3-piece compact applicator tampon | 2018 | 2 |
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?
- Of its descendants, K173225 (Albaad Fem, 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Rostam Fragranced and Unfragranced Compact Applicator Tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090071: Rostam LTD. Fragranced or Unfragranced New Plastic Applicator Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090071
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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