# K964337: Better-Bladder (BB)

- Pathway: 510(k) (Traditional)
- Applicant: Circulatory Technology, Inc.
- Decided: May 23, 1997 after 204 days
- Product code: FIB (Protector, Transducer, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

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

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140321: Initary Better Bladder-Pediatric (2014), 0 descendants of its own

## Indications for use
The Better-Bladder™ is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made. The noninvasive pressure obtained with the BB can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during routine bypass procedures.

Source page: https://510kreport.com/device/K964337
Methodology: https://510kreport.com/methodology