Cleared Traditional

K833981 - SHILEY DISPOS. TEMP. PROBES

K833981 is an FDA 510(k) clearance for SHILEY DISPOS. TEMP. PROBES, manufactured by Shiley, Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K833981 · Shiley, Inc. · General Hospital
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Mar 1984
Decision
131d
Days
Class 2
Risk

K833981 is an FDA 510(k) clearance for the SHILEY DISPOS. TEMP. PROBES. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 27, 1984 after a review of 131 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K833981

510(k) Number K833981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1983
Decision Date March 27, 1984
Days to Decision 131 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
2d slower than avg
Panel avg: 129d · This submission: 131d
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 362
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K833981.
TERUMO DIGITAL CLINICAL THERMOMETER
K841740 · Terumo Medical Corp. · Jul 1984
TYCOS SELF-CHECK/DIGITAL FEVER THERMO
K842132 · Sybron Corp. · Jul 1984
TEMPROBE MONITOR
K840648 · Vital Signs, Inc. · Jun 1984
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