# K991118: O.B. Applicator Tampons, O.B. Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Personal Products Co.
- Decided: Jun 29, 1999 after 89 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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) o.b.® non-applicator Tampons: named in the summary without a submission number
- (no number) o.b.® applicator Tampons: named in the summary without a submission number

## Most influential descendants
- K152284: Cohitech Non Applicator Organic Cotton Tampons;Cohitech Compact Applicator Organic Cotton Tampons (2015), 3 descendants of its own
- K211775: Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (2021), 2 descendants of its own
- K252939: Cohitech Organic Cotton Compact Applicator Tampons (2025), 0 descendants of its own
- K220238: Cohitech Cottonlock Tampons with Reusable Applicator (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K991118
Methodology: https://510kreport.com/methodology