510(k) · Cleared
ClearedU by Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super and Super Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · HEB Tampon, Menstrual, Unscented
Cleared on Dec 23, 2009 as substantially equivalent to K864750 (Kimberly-Clark Corp., 1987) after a 190-day review. Its family tree reaches back 1 generation to 1987. 5 later devices descend from it.
- Decided
- Dec 23, 2009
- Review
- 190 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864750 (1987). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK864750 Kotex Security Tampons, Regular and SuperKimberly-Clark Corp. · 1987
- This deviceK091749 U by Kotex Click* Unscented Tampons, Model Absorbency: Regular…Kimberly-Clark Corp. · 2009
- Descendant · cites it directly · 2 of its ownK113036 U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation · 2011
- Descendant · 2 generations on · 1 of its ownK172118 U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK223749 U by Kotex® Click® Unscented Menstrual TamponsKimberly-Clark Corporation · 2023
- Descendant · cites it directly · 0 of its ownK112635 U by Kotex Sleek Unscented Menstrual TamponsKimberly-Clark Corp. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK103311 U by Kotex Click Unscented Menstrul TamponsKimberly Clark Corporation · 2010
Most influential descendants
Showing 5 of 5 · See all- K113036U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation · 2011 · cites it directly2descendants
- K172118U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation · 2017 · 2 generations on1descendant
- K223749U by Kotex® Click® Unscented Menstrual TamponsKimberly-Clark Corporation · 2023 · 3 generations on0descendants
- K112635U by Kotex Sleek Unscented Menstrual TamponsKimberly-Clark Corp. · 2011 · cites it directly0descendants
- K103311U by Kotex Click Unscented Menstrul TamponsKimberly Clark Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864750 | Kotex Security Tampons, Regular and Super | Kimberly-Clark Corp. | 1987 | — |
| 0 (this device) | K091749 | U by Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super and… | Kimberly-Clark Corp. | 2009 | — |
| +1 | K113036 | U by Kotex Click Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2011 | — |
| +2 | K172118 | U by Kotex Click Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2017 | — |
| +3 | K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2023 | — |
| +1 | K112635 | U by Kotex Sleek Unscented Menstrual Tampons | Kimberly-Clark Corp. | 2011 | 4 |
| +1 | K103311 | U by Kotex Click Unscented Menstrul Tampons | Kimberly Clark Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K864750 | Kotex Security Tampons, Regular and SuperSummary page 1…cented Classification Name: Tampon, Menstrual, Unscented Product Code: HEB Legally marketed device Kimberly-Clark* KOTEX0 Security' Tampons - K864750 to which equivalency is claimed: Description of the device: This device is a conventional unscented menstrual tampon… | 1987 |
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?
- Its one ancestor has no recall.
- Of its descendants, K113036 (Kimberly-Clark Corporation, 2011) 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?
Kimberly-Clark* U by KOTEX® Click is an unscented menstrual tampon inserted into the vagina to absorb menstrual fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091749: U by Kotex Click* Unscented Tampons, Model Absorbency: Regular, Super and Super Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091749
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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