# K012629: Always Duets

- Pathway: 510(k) (Traditional)
- Applicant: Procter & Gamble Co.
- Decided: Oct 5, 2001 after 53 days
- Product code: HHD (Pad, Menstrual, Unscented)
- Device class: 1
- Regulation: 21 CFR 884.5435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003843 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003843: Envive Miniforms, Procter & Gamble Co. (2001)

## Indications for use
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

Source page: https://510kreport.com/device/K012629
Methodology: https://510kreport.com/methodology