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R&D Batteries, Inc. Part Numbers 5453, 5474, 5513 and 5595

FDA 510(k)

Class II (US FDA 510(k))

510(k) K951275

by R & D Batteries, Inc.

Identifiers

510(k) Number
K951275 FDA 510(k)
FDA Product Code
FLL 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)

This device is a continuous measurement thermometer classified under product code FLL, as defined by the FDA's nomenclature authority for general hospital and personal use monitoring devices under 21 CFR 880.2910. It is designed for the continuous measurement of temperature in clinical settings.

The device was submitted by R & D Batteries, Inc. of Burnsville, Minnesota, and received FDA 510(k) clearance under K951275 on August 18, 1995, following a traditional review process. It was determined to be substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device subject to special controls.

Frequently asked questions

What is the R&D Batteries Inc. continuous thermometer used for?

This device is designed for the continuous measurement of temperature in clinical settings, providing ongoing monitoring of patient temperature as part of general hospital and personal use monitoring under FDA product code FLL.

How is the R&D Batteries Inc. thermometer supplied and what are its model numbers?

The device is supplied as four specific part numbers: 5453, 5474, 5513, and 5595, manufactured by R & D Batteries, Inc. of Burnsville, Minnesota, and identified collectively in the FDA 510(k) submission as the continuous measurement thermometer.

Is the R&D Batteries Inc. thermometer sterile or single-use?

The device data does not specify sterility or single-use status; it is described as a continuous measurement thermometer for clinical use, and no information about disposability, reprocessing, or sterile packaging is provided in the authorization or specifications.

What regulatory pathway was used for the R&D Batteries Inc. thermometer?

The device received FDA 510(k) clearance under K951275 on August 18, 1995, following a traditional review process, and was determined to be substantially equivalent to a legally marketed predicate device.

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: K951275 FDA 510(k) - R&D BATTERIES | R & D Batteries, Inc., R&D Batteries, Inc. Part Numbers 5453, 5474, 5513 and 5595, R&D Batteries, Inc. Part Numbers 5453, 5474, 5513 and 5595, R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
R & D Batteries, Inc.

Sources (1)

  • FDA 510(k) K951275 24 fields · synced Sep 25, 2026