{
  "format": "devicerts.device.v1",
  "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).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/better-bladder-bb-dtn",
    "json_url": "https://devicerts.com/devices/better-bladder-bb-dtn.json",
    "markdown_url": "https://devicerts.com/devices/better-bladder-bb-dtn.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
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      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
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    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "device": {
    "name": "Better-Bladder (Bb)",
    "registry_name": "BETTER-BLADDER (BB)",
    "url": "https://devicerts.com/devices/better-bladder-bb-dtn",
    "manufacturer": {
      "name": "Circulatory Technology, Inc.",
      "url": "https://devicerts.com/manufacturers/circulatory-technology-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
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        "values": [
          {
            "value": "K981284",
            "registries": [
              "FDA 510(k)"
            ]
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        ]
      }
    ],
    "product_codes": [
      "DTN"
    ],
    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
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      "region": "United States",
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      "device_udi_di": null,
      "date": "1998-08-12",
      "date_kind": "decision",
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      "withdrawn": null,
      "status": "Active",
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      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1862-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-04-27",
      "reason": "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.",
      "applies": "this device",
      "via": "K981284"
    },
    {
      "number": "Z-1171-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-09-22",
      "reason": "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.",
      "applies": "this device",
      "via": "K981284"
    },
    {
      "number": "Z-0817-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-09-22",
      "reason": "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.",
      "applies": "this device",
      "via": "K981284"
    },
    {
      "number": "Z-2832-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2016-07-01",
      "reason": "The seal between the balloon and the housing may leak.",
      "applies": "this device",
      "via": "K981284"
    },
    {
      "number": "Z-0057-2017",
      "classification": "Class III",
      "status": "terminated",
      "initiated": "2016-07-01",
      "reason": "Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.",
      "applies": "this device",
      "via": "K981284"
    },
    {
      "number": "Z-2050-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2016-03-03",
      "reason": "The seal between the balloon and the housing may leak.",
      "applies": "this device",
      "via": "K981284"
    },
    {
      "number": "Z-1323-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2009-06-03",
      "reason": "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.",
      "applies": "this device",
      "via": "K981284"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
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          "label": "510(k) Number",
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          ]
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    }
  ]
}