# K091958: Belfort-Dildy Obstetric Tamponade System

- Pathway: 510(k) (Traditional)
- Applicant: Glenveigh Surgical, LLC
- Decided: Apr 30, 2010 after 303 days
- Product code: OQY (Intrauterine Tamponade Balloon)
- 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
Longest line of descent: 2 generations back to K972077 (1997). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062438: Bakri Postpartum Balloon, Model J-Sos-100500, Cook Ob/Gyn (2006) Summary page 1.
- K013597: Tamponade Uterine Balloon Catheter Set, Cook Ob/Gyn (2002) Summary page 1.
- K060289: Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01, Frontline Medical (2006) Summary page 1.
- K862480: BT Cath (Intravascular Catheter), Baron Technologies, Inc. (1986) Summary page 1.

## Most influential descendants
- K150573: ebb Complete Tamponade System (2015), 1 descendant of its own
- K153591: ebb Complete Tamponade System (2016), 0 descendants of its own

## Indications for use
The Belfort-Dildy Obstetric Tamponade System (OTS) is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Source page: https://510kreport.com/device/K091958
Methodology: https://510kreport.com/methodology