510(k) · Cleared
ClearedTampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble Co. · HEB Tampon, Menstrual, Unscented
Cleared on Dec 27, 2005 as substantially equivalent to K011996 (Procter & Gamble Co., 2001) and 1 other predicate after a 223-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it.
- Decided
- Dec 27, 2005
- Review
- 223 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011996 (2001). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011996 Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super…Procter & Gamble Co. · 2001
- 1 generation backK040312 Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusProcter & Gamble Co. · 2004
- This deviceK051290 Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented…Procter & Gamble Co. · 2005
- Descendant · cites it directly · 3 of its ownK081555 Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK133244 Tampax M Plastic Tampons, UnscentedThe Procter & Gamble Company · 2014
- Descendant · 2 generations on · 0 of its ownK131543 Tampax (R) L Plastic Tampons, UnscentedProcter & Gamble Co. · 2013
- Descendant · 2 generations on · 0 of its ownK110669 Tampax C Plastic Tampons, UnscentedThe Procter & Gamble Co. · 2011
- Descendant · cites it directly · 0 of its ownK091281 Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus…Procter & Gamble Co. · 2010
Most influential descendants
Showing 5 of 5 · See all- K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 2008 · cites it directly3descendants
- K133244Tampax M Plastic Tampons, UnscentedThe Procter & Gamble Company · 2014 · 2 generations on0descendants
- K131543Tampax (R) L Plastic Tampons, UnscentedProcter & Gamble Co. · 2013 · 2 generations on0descendants
- K110669Tampax C Plastic Tampons, UnscentedThe Procter & Gamble Co. · 2011 · 2 generations on0descendants
- K091281Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl…Procter & Gamble Co. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011996 | Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus | Procter & Gamble Co. | 2001 | — |
| −1 | K040312 | Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus | Procter & Gamble Co. | 2004 | — |
| 0 (this device) | K051290 | Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and… | Procter & Gamble Co. | 2005 | — |
| +1 | K081555 | Tampax Pearl Plastic Applicator Tampons, Scented and Unscented | Procter & Gamble Co. | 2008 | 1 |
| +2 | K133244 | Tampax M Plastic Tampons, Unscented | The Procter & Gamble Company | 2014 | — |
| +2 | K131543 | Tampax (R) L Plastic Tampons, Unscented | Procter & Gamble Co. | 2013 | — |
| +2 | K110669 | Tampax C Plastic Tampons, Unscented | The Procter & Gamble Co. | 2011 | — |
| +1 | K091281 | Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax… | Procter & Gamble Co. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K011996 | Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super PlusSummary page 1…Tampon (21 CFR 884.5460) Predicate Devices: TAMPAX® Pearl Plastic Applicator Tampons, Procter & Gamble, K01 1996 TAMPAX Pearl Plastic Applicator Tampons, Procter & Gamble, K040312 Devic… | 2001 |
| * | K040312 | Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusSummary page 1…Procter & Gamble, K01 1996 TAMPAX Pearl Plastic Applicator Tampons, Procter & Gamble, K040312 Device Description: The device is a conventional menstrual tampon consisting of an absorbent pledget, a withdrawal cord, and… | 2004 |
What descends from it? (5)
2 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?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081555 (Procter & Gamble Co., 2008) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K011996.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
TAMPAX® Pearl Plastic Applicator Tampons, Ultra Absorbency (unscented and scented) are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid on day(s) of heaviest menstrual flow. Ultra absorbency should not be used on days of light or moderate flow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051290: Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051290
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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