510(k) · Cleared
ClearedMaxim Plastic Applicator & Non-Applicator Tampons
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 Sep 10, 2008 after a 175-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 10, 2008
- Review
- 175 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK080775 Maxim Plastic Applicator & Non-Applicator TamponsTosama D.D. · 2008
- Descendant · cites it directly · 2 of its ownK151470 Opal by Femtex and Private Label Unscented Compact Applicator…First Quality Hygienic, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK182142 FEMME Applicator TamponJiangsu Yoai Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK161877 Opal by Femtex Pull & Snap and Private Label Unscented Compact…First Quality Hygienic, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK120481 Lil-Lets Silk Comfort Compact, Plastic Applicator, Lite, Regular…Tosama, D.O.O. · 2012
- Descendant · cites it directly · 0 of its ownK092054 Moxie Plastic Applicator and Moxie Non-Applicator TamponTosama D.D. · 2009
Most influential descendants
Showing 5 of 5 · See all- K151470Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency…First Quality Hygienic, Inc. · 2015 · cites it directly2descendants
- K182142FEMME Applicator TamponJiangsu Yoai Technology Co., Ltd. · 2019 · 2 generations on0descendants
- K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon…First Quality Hygienic, Inc. · 2016 · 2 generations on0descendants
- K120481Lil-Lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super Plus and…Tosama, D.O.O. · 2012 · cites it directly0descendants
- K092054Moxie Plastic Applicator and Moxie Non-Applicator TamponTosama D.D. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080775 | Maxim Plastic Applicator & Non-Applicator Tampons | Tosama D.D. | 2008 | — |
| +1 | K151470 | Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light… | First Quality Hygienic, Inc. | 2015 | — |
| +2 | K182142 | FEMME Applicator Tampon | Jiangsu Yoai Technology Co., Ltd. | 2019 | — |
| +2 | K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator… | First Quality Hygienic, Inc. | 2016 | — |
| +1 | K120481 | Lil-Lets Silk Comfort Compact, Plastic Applicator, Lite, Regular, Super, Super… | Tosama, D.O.O. | 2012 | — |
| +1 | K092054 | Moxie Plastic Applicator and Moxie Non-Applicator Tampon | Tosama D.D. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | — | Tampax Compak, Compact Plastic Appli. Super Tampo Named without a submission number | |
| * | — | o.b.® Non-applicator Tampons Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K151470 (First Quality Hygienic, Inc., 2015) 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. 2008, 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 MAXIM tampons (both types) are unscented tampons for:
• Women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal disctlarge.
• The plastic applicator is for easing the placement of the tampon correctly into the vagina (only the MAXIM Plastic Applicator Tampon).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080775: Maxim Plastic Applicator & Non-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/K080775
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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