Cleared Traditional

K882949 - TYMPANIC TEMPERATURE SCANNER

K882949 is an FDA 510(k) clearance for TYMPANIC TEMPERATURE SCANNER, manufactured by Omega Medical Corp.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K882949 · Omega Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
110d
Days
Class 2
Risk

K882949 is an FDA 510(k) clearance for the TYMPANIC TEMPERATURE SCANNER. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Omega Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on November 1, 1988 after a review of 110 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 Omega Medical Corp. devices

FDA 510(k) Submission Details - K882949

510(k) Number K882949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1988
Decision Date November 01, 1988
Days to Decision 110 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
19d faster than avg
Panel avg: 129d · This submission: 110d
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 607
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K882949.
CLINICAL ELECTRONIC THERMOMETERS
K884765 · Sheridan Catheter Corp. · Feb 1989
DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
K883793 · Yellow Springs Instrument Co., Inc. · Nov 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119 · S & W Medico Teknik · Nov 1988
CLINICAL ELECTRONIC THERMOMETERS
K882127 · Sheridan Catheter Corp. · Aug 1988
CLINICAL ELECTONIC THERMOMETERS
K881368 · Sheridan Catheter Corp. · Jul 1988
DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)
K882304 · Abco Dealers, Inc. · Jul 1988