510(k) Report

510(k) · Cleared

Cleared

Tampax Pearl Scented Tampons-Junior, Regular, Super & Super Plus

K040312510(k) TraditionalCleared May 3, 200484-day reviewClass II21 CFR 884.5460

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Procter & Gamble Co. · HIL Tampon, Menstrual, Scented, Scented-Deodorized

Cleared on May 3, 2004 as substantially equivalent to K011996 (Procter & Gamble Co., 2001) after an 84-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it.

Decided
May 3, 2004
Review
84 days
Class
Class II
Product code
HIL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011996 (2001). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2011: 1 descendant clearedK011996 · Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus · Procter & Gamble Co. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants K011996 · Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus · Procter & Gamble Co. · 20010
  1. Root · 1 generation backK011996 Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super…Procter & Gamble Co. · 2001
  2. This deviceK040312 Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusProcter & Gamble Co. · 2004
  3. Descendant · cites it directly · 5 of its ownK051290 Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented…Procter & Gamble Co. · 2005
  4. Descendant · cites it directly · 3 of its ownK081555 Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 2008 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK133244 Tampax M Plastic Tampons, UnscentedThe Procter & Gamble Company · 2014
  6. Descendant · 2 generations on · 0 of its ownK131543 Tampax (R) L Plastic Tampons, UnscentedProcter & Gamble Co. · 2013
  7. Descendant · 2 generations on · 0 of its ownK110669 Tampax C Plastic Tampons, UnscentedThe Procter & Gamble Co. · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12010: 12011: 12013: 12014: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • 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
  • K110669Tampax C Plastic Tampons, UnscentedThe Procter & Gamble Co. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011996Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super PlusProcter & Gamble Co.2001—
0 (this device)K040312Tampax Pearl Scented Tampons-Junior, Regular, Super & Super PlusProcter & Gamble Co.2004—
+1K051290Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and…Procter & Gamble Co.2005—
+1K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co.20081
+2K133244Tampax M Plastic Tampons, UnscentedThe Procter & Gamble Company2014—
+2K131543Tampax (R) L Plastic Tampons, UnscentedProcter & Gamble Co.2013—
+2K110669Tampax C Plastic Tampons, UnscentedThe Procter & Gamble Co.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201010
201110
201310
201410
FIG. 1 — Lineage of K040312, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K011996Tampax Pearl Scented and Unscented Tampons - Junior, Regular, Super & Super Plus
Summary page 1
…l Tampon (per 21 CFR 884.5460) Predicate Device: TAMPAX® Pearl Scented Tampons, Procter & Gamble, K01 1996 Device Description: The device is a conventional scented menstrual tampon consisting of an absorbent pledget, a withdrawal co…
Procter & Gamble Co.2001—

Also cleared against K011996: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051290Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)Procter & Gamble Co.20055
K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co.20083

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, K051290 (Procter & Gamble Co., 2005) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K011996.

How does its category compare?

All HIL devices

HIL Tampon, Menstrual, Scented, Scented-Deodorized: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIL

1in 2014

2007: 22008: 22012: 22013: 12014: 1
2007high 2 (2007) · low 0 (2009)2026

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

2007: 82008: 82009: 132010: 112011: 42012: 22013: 92014: 32015: 32016: 42017: 22018: 12019: 12020: 122021: 72022: 22023: 12024: 12025: 1
2007high 13 (2009) · low 1 (2018)2025

MAUDE reports naming product code HIL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—08
20082—08
20090—013
20100—011
20110—04
20122—02
20131—09
20141—03
20150—03
20160—04
20170—02
20180—01
20190—01
20200—012
20210—07
20220—02
20230—01
20240—01
20250—01
20260—0—

What is it indicated for?

TAMPAX® Pearl Scented Tampons are scented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

Indications for use as stated in the FDA summary.

Also cleared against K011996

3 other devices cite the same predicate.

  • K091281Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl Unscented Tampons, UltraProcter & Gamble Co. · 2010
  • K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 20081 recall
  • K051290Tampax Pearl Plastic Applicator Tampons, Ultra Absorbency (Unscented and Scented)Procter & Gamble Co. · 2005

More from Procter & Gamble Co.

23 FDA decisions under this applicant name. See the company

  • K141018Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit, Oral-B Test Drive…Procter & Gamble Co. · 2014
  • K131543Tampax (R) L Plastic Tampons, UnscentedProcter & Gamble Co. · 2013
  • K091281Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl Unscented Tampons, UltraProcter & Gamble Co. · 2010
  • K091964Crest Glide Clinical Gum Protection Dental FlossProcter & Gamble Co. · 2009
  • K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 20081 recall

Recent decisions in HIL

The HIL category page

  • K132208Ontex and Others Proprietary NamesOntex Bvba · 2014
  • K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013
  • K120245Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsPlaytex, Inc. · 2012
  • K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012
  • K081555Tampax Pearl Plastic Applicator Tampons, Scented and UnscentedProcter & Gamble Co. · 20081 recall

https://510kreport.com/device/K040312 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040312: Tampax Pearl Scented 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/K040312

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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