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Minolta PULSOX-2

by Konica Minolta Sensing, Inc. 510(k)

Active United States

510(k) K021469

Overview

The Minolta Pulsox-2 is an oxygen saturation monitor. It is a device designed to measure the oxygen saturation level in a patient's blood.

The device is supplied as a reusable monitor and is intended for use in clinical settings. It received FDA 510(k) clearance under K021469 and is classified under product code DQA. No information regarding sterility, single-use status, MRI safety, specific sizes, or storage conditions is provided in the data.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK021469 Date12 Feb 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Konica Minolta Sensing, Inc.

Questions

  • What is the Minolta Pulsox-2 used for?

    The Minolta Pulsox-2 is an oxygen saturation monitor designed to measure the oxygen saturation level in a patient's blood. It is intended for use in clinical settings to provide non-invasive monitoring of arterial oxygen saturation.

  • Is the Minolta Pulsox-2 reusable or single-use?

    The Minolta Pulsox-2 is supplied as a reusable monitor, meaning it is designed for multiple uses after appropriate cleaning and disinfection between patients, as is standard for such clinical monitoring devices.

  • What regulatory clearance does the Minolta Pulsox-2 have?

    The Minolta Pulsox-2 received FDA 510(k) clearance under submission number K021469, which was granted on February 12, 2003, confirming its substantial equivalence to a legally marketed predicate device.

  • What product code is assigned to the Minolta Pulsox-2?

    The Minolta Pulsox-2 is classified under FDA product code DQA, which is used for oximeters and related oxygen saturation monitoring devices.

  • Is the Minolta Pulsox-2 sterile or provided in a sterile condition?

    The device data does not provide any information regarding the sterility of the Minolta Pulsox-2. As a reusable monitor, it is not supplied sterile and requires user-performed cleaning and disinfection between uses.