# K002912: Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073

- Pathway: 510(k) (Traditional)
- Applicant: Sterinc
- Decided: Feb 21, 2001 after 156 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092534: Alatus Vaginal Balloon Packing System (2009), 1 descendant of its own
- K120344: Radiapak Brachytherapy Applicator Balloon Device (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K002912
Methodology: https://510kreport.com/methodology