510(k) Report

FDA applicant

Catheter Connections, Inc.

Salt Lake City, UT7 decisions2010–20151 recall

FDA records 7 decisions for Catheter Connections, Inc. (Salt Lake City, UT) from 2010 to 2015: 7 510(k) clearances. All are in product code QBP (Cap, Device Disinfectant). Its devices cite 10 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2015

2010: 12011: 12012: 22013: 12014: 12015: 1
2010high 2 (2012) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2010high 1 (2014) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Catheter Connections, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • QBPCap, Device Disinfectant7decisions

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 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.

  • K093229Catheter Connections DualcapCatheter Connections, Inc. · 20105cite it
  • K113842Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 20121cites it
  • K123065Catheter Connections Dualcap SoloCatheter Connections, Inc. · 20121cites it
  • K142806DualCapCatheter Connections, Inc. · 20151cites it

What has FDA decided for it lately?

  • K142806DualCapCatheter Connections, Inc. · 2015
  • K142399DualCap IV Pole Strips (Disinfectant Caps for Male Luers)Catheter Connections, Inc. · 2014
  • K123967Catheter Connections' Dark Blue Dualcap for Male LuersCatheter Connections, Inc. · 2013
  • K123065Catheter Connections Dualcap SoloCatheter Connections, Inc. · 20121 recall
  • K113842Catheter Connections' Dualcap SoloCatheter Connections, Inc. · 2012
  • K112985Catheter Connections' Dualcap DuoCatheter Connections, Inc. · 2011
  • K093229Catheter Connections DualcapCatheter Connections, Inc. · 2010

All 7 as Catheter Connections, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123065DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile.…Aug 5, 2014Class II

Other applicant names beginning “Catheter”

FDA records each applicant name separately; these may or may not be the same firm.

Catheter Technology Corp. 13Catheter Innovations, Inc. 8Catheter Research, Inc. 8Catheter Research C/O Burditt, Bowles & Radzius 8Catheter Robotics, Inc. 3Catheter Precision, Inc. 2Catheter Sciences Co. 2The Catheter Exchange, Inc. 1Catheter, LLC 1Catheter Corp. of America 1