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OXYLOG 2

by P.K. Morgan, Ltd. 510(k)

Active United States

510(k) K954731

Overview

The OXYLOG 2 is a Class 2 Anesthesiology device with product code BZL, designed to measure oxygen consumption. It is a computer-based oxygen uptake measurement device intended for use in monitoring oxygen consumption over periods of minutes to hours.

The device is manufactured by P.K. Morgan, Ltd. and was cleared through the Traditional 510(k) pathway on January 6, 1997, after a 448-day FDA review. It is authorized for use in anesthesiology settings and is supplied with various model numbers and reference codes as specified in the device data.

AI-generated from registry data, 27 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 NumberK954731 Date6 Jan 1997ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BZL
FDA applicant
P.K. Morgan , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.1730
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from P.K. Morgan, Ltd.

Questions

  • What is the OXYLOG 2 device used for?

    The OXYLOG 2 is a computer-based oxygen uptake measurement device designed to monitor oxygen consumption over periods of minutes to hours in anesthesiology settings.

  • How is the OXYLOG 2 supplied?

    The device is supplied with various model numbers and reference codes as specified in the device data, manufactured by P.K. Morgan, Ltd.

  • What is the regulatory status of the OXYLOG 2?

    The OXYLOG 2 is a Class 2 Anesthesiology device with product code BZL, cleared through the Traditional 510(k) pathway on January 6, 1997, after a 448-day FDA review.

  • Is the OXYLOG 2 a single-use or reusable device?

    The device data does not specify whether the OXYLOG 2 is single-use or reusable, only that it is designed to measure oxygen consumption over periods of minutes to hours.