Cleared Traditional

K832042 - LME TEMP. MONITOR

K832042 is an FDA 510(k) clearance for LME TEMP. MONITOR, manufactured by Litton Medical Electronics. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K832042 · Litton Medical Electronics · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
49d
Days
Class 2
Risk

K832042 is an FDA 510(k) clearance for the LME TEMP. MONITOR. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Litton Medical Electronics devices

FDA 510(k) Submission Details - K832042

510(k) Number K832042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1983
Decision Date August 12, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 406
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K832042.
HI-LO TEMP TYMPANIC TEMP. SENSOR
K832635 · Mallinckrodt Critical Care · Oct 1983
RECTAL TEMP. TELEMETRY MONITOR
K832404 · Xomed, Inc. · Sep 1983
TEMPERATURE MODULE 242-100
K831733 · Kontron Instruments, Inc. · Aug 1983
DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE
K830592 · Electromedics, Inc. · May 1983
TEMP TRACE
K830530 · Progress Mankind Technology · Apr 1983
MODIFICATION ELECTRONIC CLINICAL THERMO-
K830819 · Mon-A-Therm, Inc. · Apr 1983