510(k) Report

FDA applicant

Tronomed, Inc.

Mchenry, IL12 decisions1977–19961 recall

FDA records 12 decisions for Tronomed, Inc. (Mchenry, IL) from 1977 to 1996: 12 510(k) clearances. Most are in product codes FMG (Stopcock, I.V. Set) and DSA (Cable, Transducer And Electrode, Patient…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Tronomed, Inc. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Tronomed, 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?

  • FMGStopcock, I.V. Set5decisions
  • DSACable, Transducer And Electrode, Patient, (Including Connector)4decisions
  • BZQMonitor, Breathing Frequency2decisions
  • DXTInjector And Syringe, Angiographic1decision

Who builds on its devices?

Later devices cite its devices 9 times; 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.

  • K771645Electrocardiographic Cablhs & Lead WireTronomed, Inc. · 19774cite it
  • K771027Electrocardiographic Patient CablesTronomed, Inc. · 19772cite it
  • K770884Elhctrocardiographic Connecting WiresTronomed, Inc. · 19772cite it
  • K952659Tronomate Patient Cable & Leadwire SystemTronomed, Inc. · 19961cites it

What has FDA decided for it lately?

  • K952659Tronomate Patient Cable & Leadwire SystemTronomed, Inc. · 1996
  • K853303Lifelinc LeadwireTronomed, Inc. · 1985
  • K853452Life Linc Patient CableTronomed, Inc. · 1985
  • K841092High Pressure Flex. Connecting TubingTronomed, Inc. · 1985
  • K7921263&4 Way Plastic Sterile Stpcks. PKG.Tronomed, Inc. · 1980
  • K792124Tandem Assembled 3&4 Way StopcocksTronomed, Inc. · 1980
  • K792128Sterile Extension Tubes Indiv. PKG.Tronomed, Inc. · 1980
  • K7921253&4 Way Plastic Stopcocks, NonsterileTronomed, Inc. · 19801 recall

All 12 as Tronomed, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K792125Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001…Dec 18, 2015Class II