Cleared Traditional

K955846 - MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER

K955846 is an FDA 510(k) clearance for MODEL 2082 TEMP PLUS III THERMOMETER/MO..., manufactured by Y. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K955846 · Y · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
280d
Days
Class 2
Risk

K955846 is an FDA 510(k) clearance for the MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THER.... Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on October 1, 1996 after a review of 280 days - an extended review 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: 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 Y devices

FDA 510(k) Submission Details - K955846

510(k) Number K955846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date October 01, 1996
Days to Decision 280 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 129d · This submission: 280d
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 395
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K955846.
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
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K970271 · Alexander Mfg. Co. · Apr 1997
ENDOCARE ELECTORNIC THERMOMETER SYSTEM
K961365 · Endocare, Inc. · Aug 1996
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K962070 · Yellow Springs Instrument Co., Inc. · Jul 1996
OLYMPIC INFANT THERMOMETER
K954434 · Olympic Medical Corp. · Dec 1995