510(k) Report

FDA applicant

Life Sensing Instrument Company, Inc.

Tullahoma, TN5 decisions1986–19970 recalls

FDA records 5 decisions for Life Sensing Instrument Company, Inc. (Tullahoma, TN) from 1986 to 1997: 5 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and DPS (Electrocardiograph). 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, cardiovascular panel, where it files most

How often FDA has decided Life Sensing Instrument Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Life Sensing Instrument Company, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Life Sensing Instrument Company, Inc. 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?

  • DSIDetector And Alarm, Arrhythmia3decisions
  • DPSElectrocardiograph1decision
  • HETLaparoscope, Gynecologic (And Accessories)1decision

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.

  • K960884Tele Trens TM 10Life Sensing Instrument Company, Inc. · 19971cites it

What has FDA decided for it lately?

  • K960884Tele Trens TM 10Life Sensing Instrument Company, Inc. · 1997
  • K931136Apollo CameraLife Sensing Instrument Company, Inc. · 1994
  • K896967HTS 820 Cardiac MonitorLife Sensing Instrument Company, Inc. · 1990
  • K884524HTS 220 Cardiac MonitorLife Sensing Instrument Company, Inc. · 1989
  • K861067Paragon 420, Cardiac MonitorLife Sensing Instrument Company, Inc. · 1986

All 5 as Life Sensing Instrument Company, Inc. →