510(k) Report

FDA applicant

Circulatory Technology, Inc.

Oyster Bay, NY9 decisions1994–20147 recalls

FDA records 9 decisions for Circulatory Technology, Inc. (Oyster Bay, NY) from 1994 to 2014: 9 510(k) clearances. Most are in product codes DTN (Reservoir, Blood, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 3 predicates, 2 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Circulatory Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2009: 12016: 32017: 22021: 1
2007high 3 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Circulatory Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Circulatory Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DTNReservoir, Blood, Cardiopulmonary Bypass4decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions
  • FIBProtector, Transducer, Dialysis1decision
  • KZDInfusor, Pressure, For I.V. Bags1decision
  • MNJValve, Pressure Relief, Cardiopulmonary Bypass1decision

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964337Better-Bladder (BB)Circulatory Technology, Inc. · 19971cites it
  • K001822The V-BagCirculatory Technology, Inc. · 20001cites it
  • K964205Better-TubingCirculatory Technology, Inc. · 19981cites it
  • K981284Better-Bladder (BB)Circulatory Technology, Inc. · 19981cites it

What has FDA decided for it lately?

  • K140321Initary Better Bladder-PediatricCirculatory Technology, Inc. · 2014
  • K012942The V Bag, Catalog Number VB1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog Number VACBOX1500Circulatory Technology, Inc. · 2001
  • K001822The V-BagCirculatory Technology, Inc. · 2000
  • K981284Better-Bladder (BB)Circulatory Technology, Inc. · 19987 recalls
  • K964205Better-TubingCirculatory Technology, Inc. · 1998
  • K964337Better-Bladder (BB)Circulatory Technology, Inc. · 1997
  • K961594Better-VenterCirculatory Technology, Inc. · 1996
  • K941492Pressure Relief ValveCirculatory Technology, Inc. · 1994

All 9 as Circulatory Technology, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K981284The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO)…Apr 27, 2021Class II
  • K981284Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual…Sep 22, 2017Class II
  • K981284**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass…Sep 22, 2017Class II
  • K981284The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure…Jul 1, 2016Class III
  • K981284The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A…Jul 1, 2016Class II
  • K981284Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38Mar 3, 2016Class II