510(k) · Cleared
ClearedAlways Duets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble Co. · HHD Pad, Menstrual, Unscented
Cleared on Oct 5, 2001 as substantially equivalent to K003843 (Procter & Gamble Co., 2001) after a 53-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Oct 5, 2001
- Review
- 53 days
- Class
- Class I
- Product code
- HHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003843 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003843 Envive MiniformsProcter & Gamble Co. · 2001
- This deviceK012629 Always DuetsProcter & Gamble Co. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003843 | Envive Miniforms | Procter & Gamble Co. | 2001 | — |
| 0 (this device) | K012629 | Always Duets | Procter & Gamble Co. | 2001 | — |
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 HHD? 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 |
|---|---|---|---|
| * | K003843 | Envive Miniforms | 2001 |
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?
- Its one ancestor has no recall.
How does its category compare?
All HHD devicesHHD Pad, Menstrual, Unscented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHD
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HHD
Too few HHD 510(k)s in any year since 2007 to give a median.
Recalls per year · HHD
No recall names HHD since 2007.
Adverse event reports per year · HHD
11in 2025
MAUDE reports naming product code HHD, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The P&G Miniform #3 Unscented Interlabial Menstrual Pad can be worn any time of the day or night in the following ways:
Alone for light and medium (menstrual) flow
In combination with tampons or pads for extra protection during heavy (menstrual) flow
Alone for vaginal discharge or slight urine loss associated with laughs, coughs, and sneezes.
The P&G Unscented Menstrual Pad can be worn any time of the day or night in the following ways:
For menstrual flow or other vaginal discharge
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012629 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012629: Always Duets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012629
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026