Baby Pacifier Digital Thermometer
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K981456
Overview
The Baby Pacifier Digital Thermometer is a digital oral thermometer designed for measuring body temperature in infants and young children. It combines a pacifier form factor with an integrated electronic sensor to provide accurate readings, facilitating safe and convenient temperature assessment in pediatric patients.
This device is supplied as a reusable, non-sterile instrument and is intended for oral use only. It is cleared under FDA 510(k) (K981456) as substantially equivalent to a predicate device, with no specific MRI safety classification noted. Storage and handling follow standard clinical thermometry protocols, ensuring reliability for repeated use in general hospital settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981456 | Date2 Jul 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Our product lines include devices in thermometry, cardiovascular care, respiratory care and diabetes care.
Other devices from K-jump Health Co., Ltd.
Questions
How is the Baby Pacifier Digital Thermometer designed to make temperature checks easier for infants and young children?
The Baby Pacifier Digital Thermometer is designed with a pacifier form factor, allowing it to blend seamlessly into an infant’s routine while providing accurate oral temperature readings. This makes it more comfortable and less stressful for young children compared to traditional thermometers, ensuring safer and more convenient use for caregivers and clinicians.
Is this thermometer meant for single-use or repeated use in clinical settings?
The Baby Pacifier Digital Thermometer is explicitly supplied as a reusable device, not single-use. Since it is non-sterile and intended for oral use in general hospital settings, it must be cleaned and handled according to standard clinical thermometry protocols between uses to maintain accuracy and hygiene.
What kind of storage and handling instructions should I follow for this device?
The device follows standard clinical thermometry protocols for storage and handling, which typically include keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is reusable, it should be sanitized properly between uses to ensure reliable performance and prevent cross-contamination in hospital settings.
What regulatory pathway was used for FDA clearance of this thermometer?
The Baby Pacifier Digital Thermometer was cleared through the FDA 510(k) process (K981456), specifically under a Traditional review with a decision of Substantially Equivalent (SESE) to a predicate device. The submission was filed under product code FLL (General Hospital) and reviewed by the Orthopaedic and Rehabilitation Devices Panel (HO).