510(k) Report

FDA applicant

Research Medical, Inc.

Salt Lake City, UT35 decisions1984–19974 recalls

FDA records 35 decisions for Research Medical, Inc. (Salt Lake City, UT) from 1984 to 1997: 35 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DTL (Adaptor, Stopcock, Manifold, Fitting…). Its devices cite 6 predicates, 2 of them its own earlier devices. 4 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 Research Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Research Medical, Inc. since 2007.

Recalls per year

2in 2010

2008: 22010: 2
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Research Medical, 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?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass15decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass3decisions
  • DQRCannula, Catheter2decisions
  • DXCClamp, Vascular2decisions
  • DQOCatheter, Intravascular, Diagnostic2decisions
  • KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2decisions

Also: KOD (1), KYZ (1), LLL (1), DSS (1), MJN (1), FQH (1).

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 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.

  • K880103Catheter, Cannula and Tubing, Vascular, Cardiopul.Research Medical, Inc. · 19887cite it
  • K891576Fem-Flex Femoral Access Cannulation SetResearch Medical, Inc. · 19896cite it
  • K850785Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 19852cite it
  • K951344Rmi HemoconcentratorResearch Medical, Inc. · 19952cite it
  • K964833Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 19971cites it
  • K896636Rmi Anteplegia CannulaResearch Medical, Inc. · 19901cites it

What has FDA decided for it lately?

  • K970739Rmi Hemoconcentrator Preference PackResearch Medical, Inc. · 1997
  • K964833Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
  • K961927Rmi Hemoconcentractor Tubing SetResearch Medical, Inc. · 1996
  • K960098Rmi Internal Mammary Artery CannulaResearch Medical, Inc. · 1996
  • K951344Rmi HemoconcentratorResearch Medical, Inc. · 1995
  • K922083Rmi Surgiccal Site Visualization WandResearch Medical, Inc. · 1993
  • K920936Rmi External Coronary Artery OccluderResearch Medical, Inc. · 1992
  • K915869Rmi Normocluder Coronary Artery OccluderResearch Medical, Inc. · 1992

All 35 as Research Medical, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K892377Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO…Oct 19, 2010
  • K892377Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO…Oct 19, 2010
  • K033464Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x…Feb 25, 2008
  • K033464Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF…Feb 25, 2008

Other applicant names beginning “Research”

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

Research Instruments, Ltd. 9Research Development Corp. 6Research Industries Corp. 5Research Diagnostics, Inc. 3Research Consultants, Inc. 1Research Surgical Systems 1Research Instrumentation Associates, Inc. 1Research Endoscope Systems Intl. 1