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Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101387

by Fudakang Industries Co., Ltd.

Identifiers

510(k) Number
K101387 FDA 510(k)
FDA Product Code
FLL FDA 510(k)
Models / Variants
Bt-A11cn FDA 510(k)
Bt-A21cn FDA 510(k)
Bt-A41cn FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN, is a hand-held, battery-operated device designed for measuring and monitoring human body temperature. It employs a thermistor sensor to detect temperature, with an analog signal processed by an ASIC and displayed digitally on an LCD screen. The device provides audible feedback via a built-in buzzer and is intended for clinical or home use. These models are capable of axillary, oral, and rectal temperature measurements.

The thermometers are supplied as reusable, non-sterile devices intended for single-patient use per measurement cycle. They are not MRI-compatible and require no special storage conditions beyond a clean, dry environment. Each model is authorized under FDA 510(k) clearance (K101387) as substantially equivalent to predicate devices, with approval for general hospital use. No additional regulatory markings or certifications are stated beyond the FDA submission data.

Frequently asked questions

What temperature sites can the BT-A11CN, BT-A21CN, and BT-A41CN models measure?

These models are designed to measure temperature in three primary sites: axillary (underarm), oral (mouth), and rectal. The device’s thermistor sensor and digital display ensure accurate readings across these sites, making it versatile for both clinical and home use.

Are these thermometers sterile or single-use?

The BT-A11CN, BT-A21CN, and BT-A41CN are reusable devices but are intended for single-patient use per measurement cycle. While not sterile out-of-box, they are non-sterile and require cleaning between uses to maintain hygiene standards.

How should these thermometers be stored?

No special storage conditions are required beyond keeping the device in a clean, dry environment. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these could affect performance or battery life.

What distinguishes the BT-A11CN, BT-A21CN, and BT-A41CN models from each other?

The distinguishing factor between these models is not explicitly detailed in the provided data, but they share identical core specifications (e.g., measurement sites, digital display, and FDA clearance). Clarification on specific model differences (e.g., additional features or design variations) would require manufacturer documentation.

Are these thermometers compatible with MRI machines?

No, these digital thermometers are not MRI-compatible. They contain electronic components and a battery that could pose risks in an MRI environment, so they should never be used or stored near MRI equipment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Digital Thermometer, Models Bt-a11cn, Bt-a21cn, Bt-a41cn, fda.innolitics.com, Digital Thermometer, Models Bt-a11cn, Bt-a21cn, Bt-a41cn 510 (k) FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fudakang Industries Co., Ltd.

Sources (1)

  • FDA 510(k) K101387 24 fields · synced Oct 1, 2026