510(k) Report

510(k) · Cleared

Cleared

Modification to Playtex Tampons #24002

K022882510(k) SpecialCleared Sep 16, 200217-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

Playtex Products, Inc. · HIL Tampon, Menstrual, Scented, Scented-Deodorized

Cleared on Sep 16, 2002 as substantially equivalent to K020200 (Playtex Products, Inc., 2002) and 4 other predicates after a 17-day review. Its family tree reaches back 1 generation to 1983.

Decided
Sep 16, 2002
Review
17 days
Class
Class II
Product code
HIL
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K830966 (1983). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors2000: 1 other ancestor1996: 1 other ancestorK830966 · Playtex Tampons · Playtex, Inc. · 198319801985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors K830966 · Playtex Tampons · Playtex, Inc. · 19830
  1. Root · 1 generation backK830966 Playtex TamponsPlaytex, Inc. · 1983
  2. This deviceK022882 Modification to Playtex Tampons #24002Playtex Products, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830966Playtex TamponsPlaytex, Inc.1983—
0 (this device)K022882Modification to Playtex Tampons #24002Playtex Products, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200010
200220
FIG. 1 — Lineage of K022882, 1983–2002Source: 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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K020200Playtex Deodorant Tampons, Model 34802
Summary page 1
…b@ Playtex Non-deodorant & Deodorant Gentle Glide@ Multipack Tampons K020200-K020202; K993794; K96 1870; K830966 Device Description: Scented, Unscented menstrual tampons for the absorption of menstrual fl…
Playtex Products, Inc.2002—
Kept off the family treeK020201FDA’s K020201 is Playtex Deodorant Tampons, Model 34902
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Playtex Products, Inc.2002—
*K020202Playtex Deodorant Tampons, Model 34702
Summary page 1
…Playtex Non-deodorant & Deodorant Gentle Glide@ Multipack Tampons K020200-K020202; K993794; K96 1870; K830966 Device Description: Scented, Unscented menstrual tampons for the absorption of menstrual fluid. In…
Playtex Products, Inc.2002—
*K993794Platex Oder Absorbing Gentle Glide, Slimfits and Silk Glide Tampons
Summary page 1
…Playtex Non-deodorant & Deodorant Gentle Glide@ Multipack Tampons K020200-K020202; K993794; K96 1870; K830966 Device Description: Scented, Unscented menstrual tampons for the absorption of menstrual fluid. Intended Us…
Playtime Products, Inc.2000—
*K961870Playtex Slimfit Tampons
Summary page 1
…Playtex Non-deodorant & Deodorant Gentle Glide@ Multipack Tampons K020200-K020202; K993794; K96 1870; K830966 Device Description: Scented, Unscented menstrual tampons for the absorption of menstrual fluid. Intended Use: Playte…
Playtex Products, Inc.1996—
*K830966Playtex Tampons
Summary page 1
…laytex Non-deodorant & Deodorant Gentle Glide@ Multipack Tampons K020200-K020202; K993794; K96 1870; K830966 Device Description: Scented, Unscented menstrual tampons for the absorption of menstrual fluid. Intended Use: Playtex tampons…
Playtex, Inc.1983—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 5 ancestors has a recall.

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?

Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Indications for use as stated in the FDA summary.

More from Playtex Products, Inc.

17 FDA decisions under this applicant name. See the company

  • K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008
  • K072376Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc. · 2007
  • K070745Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsPlaytex Products, Inc. · 2007
  • K061013Playtex Embrace Petite Breast PumpPlaytex Products, Inc. · 20061 recall
  • K060981Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc. · 2006

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/K022882 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022882: Modification to Playtex Tampons #24002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022882

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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