# K140321: Initary Better Bladder-Pediatric

- Pathway: 510(k) (Special)
- Applicant: Circulatory Technology, Inc.
- Decided: Apr 17, 2014 after 58 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964337 (1997). 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)
- K981284: Better-Bladder (BB), Circulatory Technology, Inc. (1998) Summary page 1.
- K964337: Better-Bladder (BB), Circulatory Technology, Inc. (1997) Summary page 1.

## Indications for use
The Better-BladderN! is a device that isolates pressure transducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures.

Source page: https://510kreport.com/device/K140321
Methodology: https://510kreport.com/methodology