Cleared Traditional

K821555 - EXACON THERMOMETER SYSTEM 8000

K821555 is an FDA 510(k) clearance for EXACON THERMOMETER SYSTEM 8000, manufactured by Sat Export Engineering & Trading. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K821555 · Sat Export Engineering & Trading · General Hospital
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Aug 1982
Decision
83d
Days
Class 2
Risk

K821555 is an FDA 510(k) clearance for the EXACON THERMOMETER SYSTEM 8000. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Sat Export Engineering & Trading (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 83 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 Sat Export Engineering & Trading devices

FDA 510(k) Submission Details - K821555

510(k) Number K821555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1982
Decision Date August 16, 1982
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 613
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K821555.
HEART RATE & TEMP. MEASUREMENT SYSTEM
K822939 · Camino Laboratories, Inc. · Nov 1982
DESERT INSYTE-A HYPERTHERMIA SENSOR ACC
K823066 · Parke-Davis Co. · Nov 1982
RI 300 DIFFERENTIAL TEMPERATURE MONITOR
K822831 · Instrumentation Industries, Inc. · Oct 1982
DESERET INSYTE HYPERTHERMIA CATHETER
K821886 · Warner-Lambert Co. · Jul 1982
HI-LO TEMP SKIN TEMPERATURE SENSOR
K821833 · Mallinckrodt Critical Care · Jul 1982
THERMAL WELL TEMPERATURE SENSOR
K821504 · Mon-A-Therm, Inc. · Jun 1982