510(k) · Cleared
ClearedMoxie Plastic Applicator and Moxie Non-Applicator Tampon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosama D.D. · HEB Tampon, Menstrual, Unscented
Cleared on Jul 29, 2009 as substantially equivalent to K080775 (Tosama D.D., 2008) after a 22-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Jul 29, 2009
- Review
- 22 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080775 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK080775 Maxim Plastic Applicator & Non-Applicator TamponsTosama D.D. · 2008
- This deviceK092054 Moxie Plastic Applicator and Moxie Non-Applicator TamponTosama D.D. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080775 | Maxim Plastic Applicator & Non-Applicator Tampons | Tosama D.D. | 2008 | — |
| 0 (this device) | K092054 | Moxie Plastic Applicator and Moxie Non-Applicator Tampon | Tosama D.D. | 2009 | — |
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? (3)
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 |
|---|---|---|---|
| * | K080775 | Maxim Plastic Applicator & Non-Applicator TamponsSummary page 1…Summary of Safety and Effectiveness The MOXIE Plastic Applicator and Non Applicator Tampons are identical to MAXIM Plastic Applicator and Non Applicator tampons under K080775. The information below is identical to that approved for the MAXIM devices under K080775. Device name (trade names): MOXIE Co… | 2008 |
| * | — | Tampax Compak, Compact Plastic Applicator Named without a submission number | |
| * | — | o.b.® Non Applicator Tampons Named without a submission number |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K080775.
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 MOXIE tampons (both types) are unscented tampons for:
* Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge.
* The plastic applicator is for easing the placement of the tampon correctly into the vagina (only the MOXIE Plastic Applicator Tampon).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092054 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092054: Moxie Plastic Applicator and Moxie Non-Applicator Tampon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092054
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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