# K981284: Better-Bladder (BB)

- Pathway: 510(k) (Traditional)
- Applicant: Circulatory Technology, Inc.
- Decided: Aug 12, 1998 after 126 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: 7 (0 Class I)
- 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. The FDA summary names its predicate without a number.
- (no number) Pressure Monitoring Separator Chamber (PMS-2): named in the summary without a submission number
- (no number) R30 Assist Reservoir: named in the summary without a submission number

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

## Recalls of this device
- Apr 27, 2021 · Class II · Z-1862-2021: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause 
- Sep 22, 2017 · Class II · Z-0817-2018: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause 
- Sep 22, 2017 · Class II · Z-1171-2018: The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause 
- Jul 1, 2016 · Class III · Z-0057-2017: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
- Jul 1, 2016 · Class II · Z-2832-2016: The seal between the balloon and the housing may leak.
- Mar 3, 2016 · Class II · Z-2050-2016: The seal between the balloon and the housing may leak.
- Jun 3, 2009 · Not classified · Z-1323-2010: During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during

## 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 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/K981284
Methodology: https://510kreport.com/methodology