# K101535: BT-Cath

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products, Inc.
- Decided: Jan 11, 2011 after 222 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 K013597 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013597: Tamponade Uterine Balloon Catheter Set, Cook Ob/Gyn (2002) Summary page 1.
- K062438: Bakri Postpartum Balloon, Model J-Sos-100500, Cook Ob/Gyn (2006) Summary page 1.

## Indications for use
BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.

Source page: https://510kreport.com/device/K101535
Methodology: https://510kreport.com/methodology