510(k) Report

510(k) · Cleared

Cleared

Playtex Deodorant Tampons, Model 34902

K020201510(k) TraditionalCleared Mar 12, 200249-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 Mar 12, 2002 after a 49-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided
Mar 12, 2002
Review
49 days
Class
Class II
Product code
HIL
Recalls
None
Predicates
0

8 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 2 descendants cleared2012: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK020201 Playtex Deodorant Tampons, Model 34902Playtex Products, Inc. · 2002
  2. Descendant · cites it directly · 6 of its ownK070745 Modification to: Playtex Gentle Glide Plastic, Playtex Gentle…Playtex Products, Inc. · 2007
  3. Descendant · cites it directly · 3 of its ownK060981 Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc. · 2006
  4. Descendant · 2 generations on · 2 of its ownK111684 Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012
  5. Descendant · 3 generations on · 1 of its ownK132819 Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013
  6. Descendant · 2 generations on · 1 of its ownK073662 Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 12012: 22013: 12018: 1
2006high 2 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all
  • K070745Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsPlaytex Products, Inc. · 2007 · cites it directly6descendants
  • K060981Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc. · 2006 · cites it directly3descendants
  • K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012 · 2 generations on2descendants
  • K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013 · 3 generations on1descendant
  • K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020201Playtex Deodorant Tampons, Model 34902Playtex Products, Inc.2002—
+1K070745Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic…Playtex Products, Inc.2007—
+1K060981Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc.2006—
+2K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc.2012—
+3K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc.2013—
+2K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200810
201220
201310
201810
FIG. 1 — Lineage of K020201, 2002–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*—Playtex Deodorant Gentle Glide® in Regular, Super and Super Plus absorbencies
Named without a submission number
—
*—Playtex Deodorant Portables® in Regular and Super absorbencies
Named without a submission number
—
*—Playtex Deodorant Gentle Glide Multipack in Regular and Super absorbencies
Named without a submission number
—
*—Deodorant Slimfits® in Regular absorbency
Named without a submission number
—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K070745Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsPlaytex Products, Inc.20076
K060981Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc.20063

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, K070745 (Playtex Products, Inc., 2007) has gone furthest, with 6 descendants of its own.

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 flud.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K020201 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020201: Playtex Deodorant Tampons, Model 34902.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020201

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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