# Better-Bladder (Bb)

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/better-bladder-bb-dtn>
- Manufacturer: [Circulatory Technology, Inc.](https://devicerts.com/manufacturers/circulatory-technology-inc) (United States, FDA 510(k) applicant)
- Name in the registry: BETTER-BLADDER (BB)
- Device class: Class II (US FDA)
- FDA product code: DTN

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K981284 · decision 1998-08-12 · decision SESE · status: Active

## Recalls

- Z-1862-2021 · Class II · ongoing · initiated 2021-04-27: 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 a drop in circuit blood flow.
- Z-1171-2018 · Class II · terminated · initiated 2017-09-22: 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 a drop in circuit blood flow.
- Z-0817-2018 · Class II · terminated · initiated 2017-09-22: 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 a drop in circuit blood flow.
- Z-2832-2016 · Class II · terminated · initiated 2016-07-01: The seal between the balloon and the housing may leak.
- Z-0057-2017 · Class III · terminated · initiated 2016-07-01: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
- Z-2050-2016 · Class II · terminated · initiated 2016-03-03: The seal between the balloon and the housing may leak.
- Z-1323-2010 ·  · terminated · initiated 2009-06-03: 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 a procedure thereby obstructing flow.

## Identifiers

- 510(k) Number: K981284 [FDA 510(k)]
- FDA product code: DTN [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 870.4400 [FDA 510(k)]
- Advisory committee: Cardiovascular [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Better-Bladder (Bb), Circulatory Technology, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/better-bladder-bb-dtn (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/better-bladder-bb-dtn.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/better-bladder-bb-dtn
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.