Cleared Traditional

K823493 - CHECK MATE #1850 ELEC. DIGITAL THERMO

K823493 is the FDA 510(k) clearance for CHECK MATE #1850 ELEC. DIGITAL THERMO by Bristoline, Inc.. It is a Class 2 General Hospital device (product code FLL) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K823493 · Bristoline, Inc. · General Hospital
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Feb 1983
Decision
97d
Days
Class 2
Risk

K823493 is an FDA 510(k) clearance for the CHECK MATE #1850 ELEC. DIGITAL THERMO. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Bristoline, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1983 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bristoline, Inc. devices

Submission Details

510(k) Number K823493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1982
Decision Date February 28, 1983
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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 322
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K823493.
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
DESERET INSYTE HYPERTHERMIA CATHETER
K821886 · Warner-Lambert Co. · Jul 1982