Thermometer, Mercury/Clinical FLK
by Umax Corp.
510(k) K883573
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883573 | Date7 Nov 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Thermometer, Mercury/Clinical
- 510(k) Number
- FDA Product Code
- FLK
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2920
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a Thermometer, Mercury/Clinical, designed to measure oral, rectal, or axillary body temperature. It employs a mercury column within a glass tube to indicate temperature readings, providing a reliable and precise assessment of core body temperature in clinical settings.
The Thermometer, Mercury/Clinical FLK is intended for single-use or reusable applications in general hospital environments. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Sterility and packaging details are not specified, but it is regulated under the 880.2920 product code and must comply with applicable manufacturing and labeling standards.
Questions
AI-generated answers, 19 Sep 2026
What temperature sites can this mercury thermometer measure, and how does it provide accuracy in clinical settings?
This Umax Corp. mercury thermometer is designed to measure oral, rectal, and axillary (underarm) body temperatures. It uses a mercury column within a glass tube to visually indicate temperature readings, ensuring reliable and precise assessment of core body temperature in clinical environments. The mercury-based design provides a stable and consistent measurement method trusted for accuracy in general hospital use.
Is this thermometer intended for single-use or reusable applications, and what are the key considerations for its use?
The thermometer is explicitly labeled for single-use or reusable applications in general hospital settings. While the device itself is not described as sterile or non-sterile, its reusable nature implies it must be properly cleaned, disinfected, and maintained between uses to prevent contamination. Always follow facility protocols for reprocessing to ensure safety and compliance.
What regulatory pathway was followed for FDA clearance, and how does this affect its use in hospitals?
This thermometer received FDA 510(k) clearance under the Traditional Review pathway, determined to be substantially equivalent to predicate devices. It is classified as a Class II device, regulated under product code 880.2920, and is intended for use in general hospital environments. The clearance ensures it meets FDA standards for safety and effectiveness, making it suitable for clinical temperature monitoring as specified.
Are there different models or sizes available for this mercury thermometer, and how would I identify the correct one for my needs?
The device is listed under the product code FLK, but no specific sizes or model variations are detailed in the provided data. If multiple registration numbers (e.g., 3006210673, 3017936791) are associated with this thermometer, they may correspond to different lots or minor variations. For precise sizing or model selection, consult Umax Corp. or verify with your supplier, as clinical needs (e.g., pediatric vs. adult) may require specific thermometer lengths or designs.