Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1730](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1730) → BZL — Computer, Oxygen-Uptake

# BZL · Computer, Oxygen-Uptake

_Anesthesiology · 21 CFR 868.1730 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL

## Overview

- **Product Code:** BZL
- **Device Name:** Computer, Oxygen-Uptake
- **Regulation:** [21 CFR 868.1730](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1730)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **3rd-party reviewable:** yes

## Identification

An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (20 of 33)

Showing 20 most recent of 33 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K200076](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K200076.md) | Breezing Med | Tf Health Co. | Sep 25, 2020 | SESE |
| [K190561](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K190561.md) | NICU V'02 | Cosmed Nordic Aps | Sep 4, 2020 | SESE |
| [K110810](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K110810.md) | ANASCIENT BREATH MONITOR | Invoy Technologies, LLC | Jun 21, 2011 | SESE |
| [K093080](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K093080.md) | METAPHOR METABOLIC MONITOR | Treymed, Inc. | Jan 22, 2010 | SESE |
| [K071533](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K071533.md) | FITMATE SERIES | Cosmed Srl | Sep 28, 2007 | SESE |
| [K070858](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K070858.md) | EXPRESS SERIES | Medical Graphics Corp. | Apr 16, 2007 | SESE |
| [K061731](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K061731.md) | MEDGRAPHICS ULTIMA SYSTEM | Medical Graphics Corp. | Sep 6, 2006 | SESE |
| [K021490](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K021490.md) | REEVUE INDIRECT CALORIMETER, MODEL#8100 | Korr Medical Technologies, Inc. | Jan 2, 2003 | SESE |
| [K021605](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K021605.md) | MEDGEM | Healthetech, Inc. | Jun 14, 2002 | SESE |
| [K010577](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K010577.md) | BODYGEM, MODEL HB211 | Healthetech, Inc. | Jan 10, 2002 | SESE |
| [K954731](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K954731.md) | OXYLOG 2 | P.K. Morgan , Ltd. | Jan 6, 1997 | SESE |
| [K924978](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K924978.md) | 7250 METABOLIC MONITOR | Puritan Bennett Corp. | Sep 22, 1994 | SESE |
| [K921565](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K921565.md) | CARDIOPULMONARY METABOLIC MEASUEMENT CART | Quiton Instrument Co. | Aug 11, 1994 | SESE |
| [K931422](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K931422.md) | DELTATRAC(TM) II METABOLIC MONITOR | Datex Division Instrumentarium Corp. | Nov 24, 1993 | SESE |
| [K922660](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K922660.md) | PHYSIO-DYNE EASI - LAB | Physio-Dyne | Apr 8, 1993 | SESE |
| [K912906](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K912906.md) | MEDGRAPHICS PF/DX | Medical Graphics Corp. | Feb 4, 1992 | SESE |
| [K895791](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K895791.md) | OXYMAX | Columbus Instruments Intl. Corp. | Mar 28, 1990 | SESE |
| [K895935](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K895935.md) | ICOR CMU Q PLUS | Icor AB | Jan 4, 1990 | SESE |
| [K895586](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K895586.md) | VVR/Q CALORIMETER | Vita-Stat | Sep 22, 1989 | SESE |
| [K874663](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL/K874663.md) | MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM | Ametek/Thermox Instruments Division | May 31, 1988 | SESE |

## Top Applicants

- Medical Graphics Corp. — 4 clearances
- Beckman Instruments, Inc. — 2 clearances
- Datex Division Instrumentarium Corp. — 2 clearances
- Healthetech, Inc. — 2 clearances
- Icor AB — 2 clearances

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZL)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
