Cleared Traditional

K100495 - PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540

K100495 is an FDA 510(k) clearance for PHILIPS AVENT DIGITAL THERMOMETER SET, manufactured by Philips Electronics UK Limited. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K100495 · Philips Electronics UK Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
123d
Days
Class 2
Risk

K100495 is an FDA 510(k) clearance for the PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Philips Electronics UK Limited (Glemsford, Suffolk, GB). The FDA issued a Cleared decision on June 22, 2010 after a review of 123 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.

FDA 510(k) Submission Details - K100495

510(k) Number K100495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2010
Decision Date June 22, 2010
Days to Decision 123 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 129d · This submission: 123d
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 681
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K100495.
JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001
K101232 · Joinsoon Electronics Mfg Co, Ltd. · Jul 2010
NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED
K101736 · Shenzhen Everbest Machinery Industry Co., Ltd. · Jul 2010
RII INFRARED EAR THERMOMETER, MODEL: TH60N
K101253 · Radiant Innovation, Inc. · Jun 2010
GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA
K100563 · Geon Corporation · Jun 2010
NON-INVASIVE INFRARED (NIR)
K090386 · Medisim, Ltd. · May 2010
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
K100942 · Taidoc Technology Corporation · May 2010
K100495 · PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540
Download PDF Philips Electronics U…