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Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20

by Clearmedical, Inc. 510(k)

Active United States

510(k) K012622

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012622 Date3 Jul 2002ClearedStatusActive

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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NLF
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
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 Clearmedical/Nellcor Oxisensor II, Pediatric, Model D-20 is a reprocessed oximeter transducer accessory sensor designed for single patient use. It is intended to be connected to a Nellcor Oximeter system to acquire patient data for determining functional oxygen saturation and pulse rate in pediatric patients.

This device is supplied as a single-use transducer and is classified as a Class II medical device under regulation 870.2700. It is intended for use with previous-generation Nellcor technology and is not MRI safe. The device has FDA 510(k) clearance with number K012622, received on 2001-08-13 and decided as substantially equivalent on 2002-07-03.

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