510(k) Report

FDA applicant

Luxtron

Mchenry, IL4 decisions1982–19940 recalls

FDA records 4 decisions for Luxtron (Mchenry, IL) from 1982 to 1994: 4 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). No 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 Luxtron’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Luxtron since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Luxtron’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?

  • FLLContinuous Measurement Thermometer4decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K841105Multichannel 2000 Fluoroptic ThermometLuxtron · 19841cites it
  • K923189Luxtron Model 3100/3101/3102 MultichannelLuxtron · 19941cites it

What has FDA decided for it lately?

  • K923189Luxtron Model 3100/3101/3102 MultichannelLuxtron · 1994
  • K861623Model 3000 Mlultichannel Fluoroptic ThermometerLuxtron · 1986
  • K841105Multichannel 2000 Fluoroptic ThermometLuxtron · 1984
  • K821070Biomedical FluoropticLuxtron · 1982

All 4 as Luxtron →