510(k) · Cleared
ClearedTampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble Co. · HIL Tampon, Menstrual, Scented, Scented-Deodorized
Cleared on Sep 19, 2001 after an 84-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- Sep 19, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- HIL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK011996 Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super…Procter & Gamble Co. · 2001
- Descendant · cites it directly · 6 of its ownK040312 Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusProcter & Gamble Co. · 2004
- Descendant · cites it directly · 5 of its ownK051290 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040312Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusProcter & Gamble Co. · 2004 · cites it directly6descendants
- K051290Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)Procter & Gamble Co. · 2005 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 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 HIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040312 | Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus | 2004 | 6 |
| K051290 | Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented) | 2005 | 5 |
| K081555 | Tampax Pearl Plastic Applicator Tampons, Scented and Unscented | 2008 | 3 |
| K091281 | Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl… | 2010 | 0 |
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, K040312 (Procter & Gamble Co., 2004) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HIL devicesHIL Tampon, Menstrual, Scented, Scented-Deodorized: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HIL
Too few HIL 510(k)s in any year since 2007 to give a median.
Recalls per year · HIL
No recall names HIL since 2007.
Adverse event reports per year · HIL
1in 2025
MAUDE reports naming product code HIL, 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 | 2 | — | 0 | 8 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TAMPAX® Pearl Scented Tampons & TAMPAX® Pearl Unscented Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011996: Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011996
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026