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Basis Digital Thermometer

by Polymedica Industries, Inc. 510(k)

Active United States

510(k) K952159

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952159 Date22 Sep 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Basis Digital Thermometer is a Class II medical device designed for measuring body temperature. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA.

It is supplied by Polymedica Industries, Inc. and was cleared on September 22, 1995, under K952159. The device is intended for general hospital use and is not MRI safe unless explicitly stated in the labeling.

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