Cleared Traditional

K831150 - PANASONIC MODEL HV-5

K831150 is the FDA 510(k) clearance for PANASONIC MODEL HV-5 by Panasonic Co. Div. Matsu Elec. Corp. America. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K831150 · Panasonic Co. Div. Matsu Elec. Corp. America · General Hospital
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Apr 1983
Decision
20d
Days
Class 2
Risk

K831150 is an FDA 510(k) clearance for the PANASONIC MODEL HV-5. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Panasonic Co. Div. Matsu Elec. Corp. America (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983 after a review of 20 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 Panasonic Co. Div. Matsu Elec. Corp. America devices

Submission Details

510(k) Number K831150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1983
Decision Date April 28, 1983
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 321
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K831150.
TEMPERATURE MODULE 242-100
K831733 · Kontron Instruments, Inc. · Aug 1983
LME TEMP. MONITOR
K832042 · Litton Medical Electronics · Aug 1983
DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE
K830592 · Electromedics, Inc. · May 1983
AMER. 400 SERIES TEMP. PROBES-RECTALL
K830839 · American Pharmaseal Div. Ahsc · Apr 1983
DESERT INSYTE-A HYPERTHERMIA SENSOR ACC
K823066 · Parke-Davis Co. · Nov 1982
RI 300 DIFFERENTIAL TEMPERATURE MONITOR
K822831 · Instrumentation Industries, Inc. · Oct 1982