Cleared Traditional

DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES

K111282 · Starboard Medical, LLC · General Hospital

Aug 2011

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K111282 is an FDA 510(k) clearance for the DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Starboard Medical, LLC (Yorba Linda, US). The FDA issued a Cleared decision on August 11, 2011, 97 days after receiving the submission on May 6, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K111282 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2011
Decision Date	August 11, 2011
Days to Decision	97 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — 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.