510(k) · Cleared
ClearedTampax Compak Pearl Plastic Applicator Scented and Unscented Tampons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble Co. · HEB Tampon, Menstrual, Unscented
Cleared on Nov 22, 2006 as substantially equivalent to K880023 (Tambrands, Inc., 1988) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 22, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- HEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880023 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880023 Tampax Compak, Compact Plastic Appli. Regu. TamponTambrands, Inc. · 1988
- This deviceK062638 Tampax Compak Pearl Plastic Applicator Scented and Unscented TamponsProcter & Gamble Co. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880023 | Tampax Compak, Compact Plastic Appli. Regu. Tampon | Tambrands, Inc. | 1988 | — |
| 0 (this device) | K062638 | Tampax Compak Pearl Plastic Applicator Scented and Unscented Tampons | Procter & Gamble Co. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 HEB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HEB device
- #1 K251033 Unscented menstrual long applicator tampon…score 14.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K880023 | Tampax Compak, Compact Plastic Appli. Regu. TamponSummary page 1…Devices: TAMO'AX® Compalk Compact Plastic Applicator Tampons - Scented and Unscented Tambrands, Inc., K880023 (Regular Absorbency); K880022 (Super Absorbency) Device Description: Wie device is a conventional… | 1988 |
| * | K880022 | Tampax Compak, Compact Plastic Appli. Super TamponSummary page 1…Tampons - Scented and Unscented Tambrands, Inc., K880023 (Regular Absorbency); K880022 (Super Absorbency) Device Description: Wie device is a conventional menstrual tampon consisting of an absorbent pledget, a wit… | 1988 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All HEB devicesHEB Tampon, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HEB
82in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEB
29in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEB
452in 2025
MAUDE reports naming product code HEB, 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 | 0 | — | 0 | 38 |
| 2008 | 1 | — | 0 | 31 |
| 2009 | 7 | 136 | 0 | 30 |
| 2010 | 3 | 76 | 1 | 138 |
| 2011 | 3 | 28 | 1 | 291 |
| 2012 | 3 | 114 | 0 | 416 |
| 2013 | 2 | — | 0 | 259 |
| 2014 | 4 | 173 | 0 | 167 |
| 2015 | 5 | 114 | 0 | 132 |
| 2016 | 1 | — | 0 | 101 |
| 2017 | 2 | — | 0 | 194 |
| 2018 | 5 | 140 | 4 | 363 |
| 2019 | 7 | 182 | 0 | 3,034 |
| 2020 | 2 | — | 0 | 1,714 |
| 2021 | 6 | 60 | 0 | 1,403 |
| 2022 | 3 | 81 | 0 | 1,055 |
| 2023 | 5 | 109 | 0 | 702 |
| 2024 | 2 | — | 0 | 534 |
| 2025 | 6 | 82 | 29 | 452 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
TAMPAX® Compak Pearl Plastic Applicator Scented Tampons and TAMPAX® Compak Pearl Plastic Applicator Unscented Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062638: Tampax Compak Pearl Plastic Applicator Scented and Unscented Tampons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062638
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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