510(k) · Cleared
ClearedPlaytex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Playtex, Inc. · HIL Tampon, Menstrual, Scented, Scented-Deodorized
Cleared on Jun 21, 2012 as substantially equivalent to K073662 (Playtex Products, Inc., 2008) and 2 other predicates after a 146-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Jun 21, 2012
- Review
- 146 days
- Class
- Class II
- Product code
- HIL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K830966 (1983). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK830966 Playtex TamponsPlaytex, Inc. · 1983
- 2 generations backK070745 Modification to: Playtex Gentle Glide Plastic, Playtex Gentle…Playtex Products, Inc. · 2007
- 1 generation backK072376 Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc. · 2007
- This deviceK120245 Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide…Playtex, Inc. · 2012
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 | K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic… | Playtex Products, Inc. | 2007 | — |
| −1 | K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons | Playtex Products, Inc. | 2007 | — |
| 0 (this device) | K120245 | Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented Tampons | Playtex, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K073662 | Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsSummary page 1…nted Classification Code HIL, HEB Predicate Devices Playtex'o Gentle Glide and Playtexo Gentle Glide Multipack Tampons (K073662) Playtex®O Gentle Glide Plastic and Playtex® Gentle Glide Plastic Mult… | 2008 |
| * | K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsSummary page 1…(K073662) Playtex®O Gentle Glide Plastic and Playtex® Gentle Glide Plastic Multipack Tampons (K070745) Playtex® Non-deodorant Gentle Glide (unscented), Playtex Deodorant Ge… | 2007 |
| * | K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsSummary page 1…unscented), Playtex Deodorant Gentle Glide (Scented) and Playtex Non-deodorant and Deodorant Multipack Tampons (K072376) Device Description Scented or scented deodorized, unscented menstrual tampons for the ab… | 2007 |
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?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- None of the 7 ancestors has a recall.
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. 2012, 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® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb mnenstrual fluid.
Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120245: Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120245
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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