510(k) · Cleared
ClearedPlaytex Slimfit 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 Jun 19, 1996 after a 40-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 19, 1996
- Review
- 40 days
- Class
- Class II
- Product code
- HIL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK961870 Playtex Slimfit TamponsPlaytex Products, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK073662 Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK120245 Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide…Playtex, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK022882 Modification to Playtex Tampons #24002Playtex Products, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See all- K073662Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsPlaytex Products, Inc. · 2008 · cites it directly1descendant
- K120245Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented TamponsPlaytex, Inc. · 2012 · 2 generations on0descendants
- K022882Modification to Playtex Tampons #24002Playtex Products, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961870 | Playtex Slimfit Tampons | Playtex Products, Inc. | 1996 | — |
| +1 | K073662 | Playtex Gentile Glide, Playtex Gentile Glide Multipack Tampons | Playtex Products, Inc. | 2008 | — |
| +2 | K120245 | Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented Tampons | Playtex, Inc. | 2012 | — |
| +1 | K022882 | Modification to Playtex Tampons #24002 | Playtex Products, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Playtex Tampons #12496 (Slimfit Tampon) Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K073662 (Playtex Products, Inc., 2008) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K961870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961870: Playtex Slimfit Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961870
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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