510(k) · Cleared
ClearedPlaytex (Scented and Unscented) Sport Fresh Balance Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Playtex Manufacturing, Inc. · HIL Tampon, Menstrual, Scented, Scented-Deodorized
Cleared on Oct 9, 2013 as substantially equivalent to K111684 (Playtex Manufacturing, Inc., 2012) after a 30-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- Oct 9, 2013
- Review
- 30 days
- Class
- Class II
- Product code
- HIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K830966 (1983). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK830966 Playtex TamponsPlaytex, Inc. · 1983
- 2 generations backK060981 Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsPlaytex Products, Inc. · 2006
- 1 generation backK111684 Playtex Sport (Unscented) ,(Scented) with OdorshieldPlaytex Manufacturing, Inc. · 2012
- This deviceK132819 Playtex (Scented and Unscented) Sport Fresh Balance TamponsPlaytex Manufacturing, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK180167 Playtex Stella TamponsPlaytex Manufacturing, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180167Playtex Stella TamponsPlaytex Manufacturing, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830966 | Playtex Tampons | Playtex, Inc. | 1983 | — |
| −2 | K060981 | Playtex Sport Plastic, Playtex Sport Plastic Multipack Tampons | Playtex Products, Inc. | 2006 | — |
| −1 | K111684 | Playtex Sport (Unscented) ,(Scented) with Odorshield | Playtex Manufacturing, Inc. | 2012 | — |
| 0 (this device) | K132819 | Playtex (Scented and Unscented) Sport Fresh Balance Tampons | Playtex Manufacturing, Inc. | 2013 | — |
| +1 | K180167 | Playtex Stella Tampons | Playtex Manufacturing, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111684 | Playtex Sport (Unscented) ,(Scented) with OdorshieldSummary page 1…strual fluid. Technological The modified tampons have the same technological characteristics as the Characteristics predicate devices (K 111684) as they have the same design, absorbency and… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180167 | Playtex Stella Tampons | 2018 | 0 |
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K180167 (Playtex Manufacturing, Inc., 2018) has gone furthest, with 0 descendants of its own.
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. 2013, 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?
Playtex scented (or scented deodorized) and unscented menstrual tampons are intended to
be inserted into the vagina and used to absorb menstrual fluid.
Absorbs menstrual flow < 6 grams (Light)
Absorbs menstrual flow 6-9 gram (Regular)
Absorbs menstrual flow 9-12 grams (Super)
Absorbs menstrual flow 12-15 grams (Super Plus)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132819 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132819: Playtex (Scented and Unscented) Sport Fresh Balance Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132819
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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