510(k) Report

FDA applicant

Sorensen Research

Mchenry, IL69 decisions1976–19843 recalls

FDA records 69 decisions for Sorensen Research (Mchenry, IL) from 1976 to 1984: 69 510(k) clearances. Most are in product codes KOC (Accessories, Blood Circuit, Hemodialysis) and CAC (Apparatus, Autotransfusion). 3 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, gastroenterology and urology panel, where it files most

How often FDA has decided Sorensen Research’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sorensen Research since 2007.

Recalls per year

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • KOCAccessories, Blood Circuit, Hemodialysis22decisions
  • CACApparatus, Autotransfusion7decisions
  • DRSTransducer, Blood-Pressure, Extravascular7decisions
  • FIENeedle, Fistula6decisions
  • DYBIntroducer, Catheter4decisions
  • GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered3decisions

Also: FJT (3), KDP (2), DYG (2), DRQ (2), KRB (1), DQO (1).

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K831506Disp. Transducer W/Monitoring Kit TransSorensen Research · 19831cites it

What has FDA decided for it lately?

  • K833674Accurate Measurement Device KG-AmdSorensen Research · 1984
  • K833673Accurate Measurement Device EZ-AmdSorensen Research · 1983
  • K833096Transducer Dome DS106Sorensen Research · 1983
  • K833095Transducer Dome SD105Sorensen Research · 1983
  • K833094Transducer Dome SD104Sorensen Research · 1983
  • K832957Flow-Directed Heparin Coated ThermodilSorensen Research · 19831 recall
  • K831506Disp. Transducer W/Monitoring Kit TransSorensen Research · 19832 recalls
  • K831939Tall Floor Stand TFS-01Sorensen Research · 1983

All 69 as Sorensen Research →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K831506ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port…Nov 27, 2018Class II
  • K813464Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with…Jan 9, 2006
  • K812800Pentalumen TD Thermodilution Catheter, SterileNov 19, 2003