510(k) · Cleared
ClearedPlaytex Gentle Glide, Playtex Gentle Glide Multipack Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Playtex Products, Inc. · HIL Tampon, Menstrual, Scented, Scented-Deodorized
Cleared on Dec 12, 2007 as substantially equivalent to K070745 (Playtex Products, Inc., 2007) after a 110-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Dec 12, 2007
- Review
- 110 days
- Class
- Class II
- Product code
- HIL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K830966 (1983). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK830966 Playtex TamponsPlaytex, Inc. · 1983
- 1 generation backK070745 Modification to: Playtex Gentle Glide Plastic, Playtex Gentle…Playtex Products, Inc. · 2007
- This deviceK072376 Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsPlaytex Products, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK120245 Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide…Playtex, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K120245Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsPlaytex, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830966 | Playtex Tampons | Playtex, Inc. | 1983 | — |
| −1 | K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic… | Playtex Products, Inc. | 2007 | — |
| 0 (this device) | K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons | Playtex Products, Inc. | 2007 | — |
| +1 | 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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsSummary page 1…dified) Devices: Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons K070745 Device Description: Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid. === Page… | 2007 |
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 |
|---|---|---|---|
| K120245 | Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented Tampons | 2012 | 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 24 years and passes through 2 companies; a new generation was cleared every 24.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120245 (Playtex, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K070745.
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. 2007, 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?
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.
https://510kreport.com/device/K072376 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072376: Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072376
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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