# K974629: O.B. Applicator and Non-Applicator Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Personal Products Co.
- Decided: Feb 10, 1998 after 60 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) current commercial 0.b.® tampons: named in the summary without a submission number

## Indications for use
0.b.® Tampons are used to absorb menstrual fluid or other vaginal discharge.

Source page: https://510kreport.com/device/K974629
Methodology: https://510kreport.com/methodology