B-D Assure Ear Thermometer
by Becton Dickinson Consumer Products
510(k) K971994
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971994 | Date1 May 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The B-D Assure Ear Thermometer is a tympanic membrane thermometer (Device Type: FLL) designed to measure core body temperature by detecting infrared radiation emitted from the tympanic membrane. It provides rapid, non-invasive temperature readings by inserting the probe into the ear canal, where the sensor aligns with the tympanic membrane for accurate assessment. This device is classified under regulatory category II and is intended for use in general hospital settings, as defined by the FDA’s advisory committee classification.
The device is supplied as a single-use, sterile disposable probe system, ensuring hygiene and reducing cross-contamination risk. It is intended for use in clinical environments where quick, reliable temperature monitoring is required, such as pediatric and adult patient care. The thermometer adheres to FDA 510(k) clearance (K971994) under the Traditional review pathway, with no third-party involvement noted. Storage and handling follow standard sterile disposable protocols, and its design complies with regulatory standards for infrared thermometry in ear canal applications.
Other devices from Becton Dickinson Consumer Products
Questions
AI-generated answers, 1 Oct 2026
What is the B-D Assure Ear Thermometer designed for?
The B-D Assure Ear Thermometer is a tympanic membrane thermometer designed to measure core body temperature by detecting infrared radiation from the tympanic membrane. It provides quick, non-invasive readings by inserting a disposable probe into the ear canal, aligning the sensor with the membrane for accurate assessment. This makes it suitable for clinical environments requiring reliable temperature monitoring, such as pediatric and adult patient care.
Is the B-D Assure Ear Thermometer single-use or reusable?
The B-D Assure Ear Thermometer is supplied as a single-use, sterile disposable probe system. This design ensures hygiene and minimizes cross-contamination risk, which is critical in clinical settings where multiple patients may be monitored. Each probe is intended for one-time use only.
How should the B-D Assure Ear Thermometer be stored?
The device follows standard sterile disposable protocols for storage and handling. Since it is a single-use, sterile probe system, it should be stored in its original packaging until use. Proper storage conditions—such as protection from moisture, extreme temperatures, and contamination—are essential to maintain sterility and device integrity before use.
What regulatory pathway does the B-D Assure Ear Thermometer follow?
The B-D Assure Ear Thermometer is cleared under the FDA 510(k) Traditional review pathway with clearance number K971994. It is classified under regulatory category II and is intended for use in general hospital settings, as defined by the FDA’s advisory committee classification. The device adheres to FDA standards for infrared thermometry in ear canal applications.
Why is the probe disposable and sterile?
The disposable and sterile probe design eliminates the need for cleaning or reprocessing between uses, reducing the risk of infection and contamination. This is particularly important in clinical settings where multiple patients may be monitored, as it ensures each measurement is taken with a clean, sterile probe, maintaining accuracy and patient safety.