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Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe

by Midwest Reprocessing Center, LLC

510(k) K101280

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101280 Date7 Oct 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NLF
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe is a reprocessed pulse oximeter probe. It is used with compatible pulse oximeter instruments to perform as intended and is safe and effective. The device has undergone non-clinical functional testing, cleaning validation, and biocompatibility testing. The probe is classified as a class 2 device.

The Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe is supplied as a reprocessed device. It has been cleared by the FDA under the traditional clearance type with the decision code SESE. The device is associated with the product code NLF and regulation number 870.2700. The probe is intended for use in the cardiovascular medical specialty.

Other devices from Midwest Reprocessing Center, LLC

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the intended use of the Reprocessed Pulse Oximeter Probe?

    The probe is intended for use in the cardiovascular medical specialty to perform as intended and is safe and effective with compatible pulse oximeter instruments.

  • Is the Reprocessed Pulse Oximeter Probe supplied sterile?

    The description does not explicitly state that the device is supplied sterile, but it has undergone cleaning validation and biocompatibility testing.

  • What type of testing has the Reprocessed Pulse Oximeter Probe undergone?

    The device has undergone non-clinical functional testing, cleaning validation, and biocompatibility testing to ensure safety and effectiveness.

  • What is the classification of the Reprocessed Pulse Oximeter Probe?

    The probe is classified as a class 2 device.