Digital Forehead Thermometer, Model KD-2200
by K-jump Health Co., Ltd. 510(k)
Active
510(k) K070491
Overview
The Digital Forehead Thermometer, Model KD-2200, is a continuous measurement thermometer designed for non-invasive temperature monitoring. It employs a probe with a thermistor sensor and a stainless steel plate to detect temperature changes in the forehead, converting these signals into digital readings via an ASIC circuit on a printed circuit board. The device displays results on an LCD screen, providing accurate and rapid temperature assessment.
This single-use device is intended for use in general hospital settings and complies with ASTM standards. Supplied as a sterile, disposable unit, it requires no special storage conditions beyond standard room temperature. The device holds an FDA 510(k) clearance under product code FLL, classified under regulation 880.2910, and is intended for reusable or single-use applications as determined by facility policy.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070491 | Date21 Jun 2007 | 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- Withdrawn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
Other devices from K-jump Health Co., Ltd.
Questions
Is this thermometer designed for repeated use in a single patient or for multiple patients, and how does that affect its handling?
The KD-2200 is a single-use device, supplied sterile and disposable, meaning it should not be reused on multiple patients. While the FDA clearance under product code FLL technically allows for reusable or single-use applications based on facility policy, the manufacturer’s labeling and ASTM compliance confirm it is intended for one-time use only. This eliminates the need for reprocessing but requires proper disposal after a single measurement to maintain infection control.
What storage conditions are required for the KD-2200 before use, and how long can it remain unused before it should be discarded?
The device does not require special storage conditions beyond standard room temperature. There is no explicit expiration or shelf-life mentioned in the data, but as a single-use, sterile item, it should be used promptly after opening. If stored properly, it should remain viable until the packaging is compromised or the device is used, though facilities should follow their own policies for unused sterile disposables.
How does the KD-2200’s measurement technology differ from traditional mercury or digital oral thermometers, and what makes it suitable for hospital use?
Unlike mercury or oral thermometers, the KD-2200 uses a non-invasive forehead probe with a thermistor sensor and stainless steel plate to detect temperature via an ASIC circuit, eliminating the need for oral contact. This design reduces cross-contamination risk, aligns with ASTM standards for accuracy, and is ideal for general hospital settings where rapid, hygienic screening is critical. The digital LCD display also provides immediate, clear readings without patient discomfort.
Can this thermometer be used for patients of all ages, or are there specific patient populations it’s not recommended for?
The KD-2200 is designed for general hospital use, implying it is intended for adult and pediatric patients where forehead temperature measurement is clinically relevant. However, the data does not specify exclusions for infants, elderly patients, or those with conditions affecting forehead temperature accuracy (e.g., fever blisters, cold packs, or extreme hair coverage). Clinicians should verify forehead accessibility and follow facility protocols for vulnerable populations.