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Oximax Softcare Sensors Models SC-A, SC-PR, SC-NEO, SC-N

by Nellcor Puritan Bennett, Inc.

510(k) K030930

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030930 Date23 May 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Models / Variants
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 Oximax Softcare Sensors are pulse oximetry devices designed to transmit radiation at known wavelengths through blood to measure blood oxygen saturation. These sensors utilize a soft, pliable, low-profile foam material that provides stiction to remain in place without the use of adhesives, fastening instead with a hook and loop strap.

These sensors are intended for single-patient use and are available in models SC-A for adults over 40 kg, SC-PR for preterm infants under 1.5 kg, SC-NEO for neonates 1.5 to 5 kg, and SC-N for neonates under 3 kg. The device has received FDA 510k clearance.

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Questions

AI-generated answers, 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.

  • What are Oximax Softcare Sensors used for?

    The Oximax Softcare Sensors are pulse oximetry devices designed to measure blood oxygen saturation by transmitting radiation at specific wavelengths through the blood.

  • Are these sensors intended for single-patient use?

    These sensors are designed for single-patient use to maintain hygiene and prevent cross-contamination between different individuals.

  • What size models are available for these sensors?

    The sensors are available in four models based on patient weight: SC-A for adults over 40 kg, SC-PR for preterm infants under 1.5 kg, SC-NEO for neonates 1.5 to 5 kg, and SC-N for neonates under 3 kg.

  • How do the Oximax Softcare Sensors attach to the patient?

    These sensors feature a soft, pliable foam material that uses a hook and loop strap for fastening, providing stiction to remain in place without the need for adhesives.