510(k) · Cleared
Recalled · Class II · 2025Tampax Pearl Plastic Applicator Tampons, Scented and Unscented
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 Jun 27, 2008 as substantially equivalent to K011996 (Procter & Gamble Co., 2001) and 2 other predicates after a 24-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2008
- Review
- 24 days
- Class
- Class II
- Product code
- HIL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011996 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK011996 Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super…Procter & Gamble Co. · 2001
- 2 generations backK040312 Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusProcter & Gamble Co. · 2004
- 1 generation backK051290 Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented…Procter & Gamble Co. · 2005
- This deviceK081555 Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 2008
- Descendant · cites it directly · 0 of its ownK133244 Tampax M Plastic Tampons, UnscentedThe Procter & Gamble Company · 2014
- Descendant · cites it directly · 0 of its ownK131543 Tampax (R) L Plastic Tampons, UnscentedProcter & Gamble Co. · 2013
- Descendant · cites it directly · 0 of its ownK110669 Tampax C Plastic Tampons, UnscentedThe Procter & Gamble Co. · 2011
Most influential descendants
Showing 3 of 3 · See all- K133244Tampax M Plastic Tampons, UnscentedThe Procter & Gamble Company · 2014 · cites it directly0descendants
- K131543Tampax (R) L Plastic Tampons, UnscentedProcter & Gamble Co. · 2013 · cites it directly0descendants
- K110669Tampax C Plastic Tampons, UnscentedThe Procter & Gamble Co. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011996 | Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus | Procter & Gamble Co. | 2001 | — |
| −2 | 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 | — |
| 0 (this device) | K081555 | Tampax Pearl Plastic Applicator Tampons, Scented and Unscented | Procter & Gamble Co. | 2008 | — |
| +1 | K133244 | Tampax M Plastic Tampons, Unscented | The Procter & Gamble Company | 2014 | — |
| +1 | K131543 | Tampax (R) L Plastic Tampons, Unscented | Procter & Gamble Co. | 2013 | — |
| +1 | K110669 | Tampax C Plastic Tampons, Unscented | The Procter & Gamble Co. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K011996 | Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super PlusSummary page 1…al tampon (21 CFR 884.5460) PredicateDevices: TAMPAX Pearl Tampons ® unscented and scented K011996; K040312; K051290 Device Description: Scented or scented deodorized, unscented menstrual… | 2001 |
| * | K040312 | Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusSummary page 1…(21 CFR 884.5460) PredicateDevices: TAMPAX Pearl Tampons ® unscented and scented K011996; K040312; K051290 Device Description: Scented or scented deodorized, unscented menstrual tampo… | 2004 |
| * | K051290 | Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)Summary page 1…(21 CFR 884.5460) PredicateDevices: TAMPAX Pearl Tampons ® unscented and scented K011996; K040312; K051290 Device Description: Scented or scented deodorized, unscented menstrual tampons for ab… | 2005 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2025 | Class II | Z-1182-2026 | Storage | Potential exposure of rodents and rodent activity in the distribution center. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133244 (The Procter & Gamble Company, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011996.
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. 2008, this device’s year, is highlighted.
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?
The TAMPAX ® Pearl Plastic unscented and scented Tampons are intended to be inserted into the vagina to absorb menstrual fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081555: Tampax Pearl Plastic Applicator Tampons, Scented and Unscented.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081555
Report an extraction error
Are you the manufacturer?
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