510(k) · Cleared
ClearedInterlude Rolled Tampons in Plastic Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Albaad Fem · HEB Tampon, Menstrual, Unscented
Cleared on Oct 7, 2019 as substantially equivalent to K173225 (Albaad Fem, 2018) after a 131-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Oct 7, 2019
- Review
- 131 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090071 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK090071 Rostam LTD. Fragranced or Unfragranced New Plastic Applicator TamponsRostam, Ltd. · 2009
- 1 generation backK173225 Interlude and private label Unscented 3-piece compact applicator…Albaad Fem · 2018
- This deviceK191431 Interlude Rolled Tampons in Plastic ApplicatorAlbaad Fem · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K191431 | Interlude Rolled Tampons in Plastic Applicator | Albaad Fem | 2019 | — |
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 |
|---|---|---|---|
| * | K173225 | Interlude and private label Unscented 3-piece compact applicator tamponSummary page 4…Product Code: HEB 5. Predicate Device Information The predicate device is Interlude and private label Unscented 3-piece compact applicator tampon (K173225). This predicate device has not been subject to a design-related recall. 6. Device Description Interlude rolled tampons in plas… | 2018 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K173225.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Interlude rolled tampons in plastic applicator 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/K191431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191431: Interlude Rolled Tampons in Plastic Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191431
Report an extraction error
Are you the manufacturer?
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