510(k) Report

510(k) · Cleared

Cleared

Playtex Non-Deodorant/Deodorant Tampons

K912002510(k) TraditionalCleared Aug 12, 199198-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 Family Products, Inc. · HIL Tampon, Menstrual, Scented, Scented-Deodorized

Cleared on Aug 12, 1991 after a 98-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.

Decided
Aug 12, 1991
Review
98 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 cleared1990200020102020
  1. This deviceK912002 Playtex Non-Deodorant/Deodorant TamponsPlaytex Family Products, Inc. · 1991
  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)K912002Playtex Non-Deodorant/Deodorant TamponsPlaytex Family Products, Inc.1991—
+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 K912002, 1991–2018Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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—

More from Playtex Family Products, Inc.

17 FDA decisions under this applicant name. See the company

  • K941196Platex Tampons Model Number 07094Playtex Family Products, Inc. · 1994
  • K940821Playtex Tampons #04994 Unscented & ScentedPlaytex Family Products, Inc. · 1994
  • K932907Playtex Ultimates TamponsPlaytex Family Products, Inc. · 1994
  • K934083Playtex Ultimates TamponsPlaytex Family Products, Inc. · 1994
  • K936189Playtex Ultimates Tampons/Unscented and ScentedPlaytex Family Products, Inc. · 1994

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/K912002 · printed Nov 5, 2026

Cite this page

510(k) Report. “K912002: Playtex Non-Deodorant/Deodorant Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K912002

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026