Thermometer, Electronic, Clinical

Device Code: 2545

Product Code(s): FLL

Device Classification Information

• Device Type ID: 2545
• Device Name: Thermometer, Electronic, Clinical
• Regulation Description: Clinical Electronic Thermometer.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.2910 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FLL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 6-124 ASTM E1104-98 (Reapproved 2016)
  Standard Specification For Clinical Thermometer Probe Covers And Sheaths
• 6-125 ASTM E1965-98 (Reapproved 2016)
  Standard Specification For Infrared Thermometers For Intermittent Determination Of Patient Temperature
• 6-177 ASTM E1112-00 (Reapproved 2011)
  Standard Specification For Electronic Thermometer For Intermittent Determination Of Patient Temperature
• 6-403 ISO 80601-2-56 Second Edition 2017-03
  Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
• 13-52 IEEE ISO 11073-10408 First Edition 2010-05-01
  Health Informatics - Point-of-care Medical Device Communication - Part 10408: Device Specialization - Thermometer

Total Product Life Cycle

• Device Type ID: 2545
• Device: Thermometer, Electronic, Clinical
• Product Code: FLL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Clinical Electronic Thermometer.
• CFR Regulation Number: 880.2910 [🔎]

Premarket Reviews
Manufacturer	Decision
AVITA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BIOCARE ASIA CORPORATION LTD.
	SUBSTANTIALLY EQUIVALENT	2
EASYWELL BIOMEDICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FIAB SPA
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG BIOLIGHT MEDITECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU UNIVERSAL ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIWORKS LLC
	SUBSTANTIALLY EQUIVALENT	1
INTRINITY GLOBAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
KAZ USA, INC (A SUBSIDIARY OF KAZ INC)
	SUBSTANTIALLY EQUIVALENT	1
KAZ USA, INC., A HELEN OF TROY COMPANY
	SUBSTANTIALLY EQUIVALENT	6
KINSA, INC.
	SUBSTANTIALLY EQUIVALENT	1
K-JUMP HEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
K-JUMP HEATH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
MEDIANA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDISIM LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROLIFE
	SUBSTANTIALLY EQUIVALENT	1
MICROLIFE INTELLECTUAL PROPERTY GMBH
	SUBSTANTIALLY EQUIVALENT	1
NEXMED TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PINGHU SAMA MEDICAL PACKING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
RADIANT INNOVATION, INC.
	SUBSTANTIALLY EQUIVALENT	2
RAIING MEDICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
RUDOLF RIESTER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN JIACOM TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN LAUNCH ELECTRICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHONTEK ELECTRONICS CO., LTD(CHINA)
	SUBSTANTIALLY EQUIVALENT	1
TAIDOC TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TECNIMED S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
WITHINGS
	SUBSTANTIALLY EQUIVALENT	1
XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Thermometer	87
Adverse Event Without Identified Device Or Use Problem	65
Power Problem	34
Battery Problem	27
Product Quality Problem	27
Nonstandard Device	27
Device Issue	22
Insufficient Information	21
False Negative Result	17
Invalid Sensing	15
Device Operates Differently Than Expected	10
Thermal Decomposition Of Device	8
Device Reprocessing Problem	7
Improper Or Incorrect Procedure Or Method	6
Manufacturing, Packaging Or Shipping Problem	6
Low Sensing Threshold	4
Temperature Problem	4
Use Of Device Problem	3
Device Operational Issue	2
Defective Component	1
Low Readings	1
Device Sensing Problem	1
Display Difficult To Read	1
No Apparent Adverse Event	1
Appropriate Term/Code Not Available	1
Incorrect Measurement	1
Contamination / Decontamination Problem	1
Missing Value Reason	1
Overheating Of Device	1
Output Problem	1
Break	1
Display Or Visual Feedback Problem	1
Device Alarm System	1
Calibration Error	1
Computer Software Problem	1
Erratic Or Intermittent Display	1
Device Handling Problem	1
Failure To Clean Adequately	1
Total Device Problems	411

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Nov-18-2017
2	Bestmed, LLC	II	Dec-16-2015
3	Measurement Specialties Inc	II	Jan-19-2018
4	Philips Consumer Lifestyle	II	Feb-22-2018

TPLC Last Update: 2019-04-02 20:14:21