510(k) · Cleared

Cleared

Breezing Med

K200076510(k) TraditionalCleared Sep 25, 2020255-day reviewClass II21 CFR 868.1730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tf Health Co. · BZL Computer, Oxygen-Uptake

Cleared on Sep 25, 2020 as substantially equivalent to K070858 (Medical Graphics Corp., 2007) after a 255-day review. Its family tree reaches back 3 generations to 1996.

Decided: Sep 25, 2020
Review: 255 days
Class: Class II
Product code: BZL
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K955432 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK955432 CPX, CCM, Cath with 15% CO2Medical Graphics Corp. · 1996
2 generations backK061731 Medgraphics Ultima SystemMedical Graphics Corp. · 2006
1 generation backK070858 Express SeriesMedical Graphics Corp. · 2007
This deviceK200076 Breezing MedTf Health Co. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K955432	CPX, CCM, Cath with 15% CO2	Medical Graphics Corp.	1996	—
−2	K061731	Medgraphics Ultima System	Medical Graphics Corp.	2006	—
−1	K070858	Express Series	Medical Graphics Corp.	2007	—
0 (this device)	K200076	Breezing Med	Tf Health Co.	2020	—

FIG. 1 — Lineage of K200076, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new BZL device

#1 K190561 NICU V'02score 2.4 · 9 generations · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K070858	Express Series Summary page 4 …Name: Indirect calorimeter • Classification Name: Computer, Oxygen Update (21 CFR 868.1730, product code BZL) 3. Predicate Device: Express Series (K070858) 4. Device Description Breezing Med™ Metabolism Analyzer is a resting metabolic rate measurement system with an application in…	Medical Graphics Corp.	2007	—

Also cleared against K070858: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K070858.

How does its category compare?

All BZL devices

BZL Computer, Oxygen-Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · BZL

2in 2020

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZL

Too few BZL 510(k)s in any year since 2007 to give a median.

Recalls per year · BZL

No recall names BZL since 2007.

Adverse event reports per year · BZL

1in 2023

2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code BZL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	2	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (139 words)

Breezing Med™ Metabolism Analyzer measures metabolic functions including resting energy expenditure and respiratory quotient during resting conditions via direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements, and to quantify substrate utilization. The nutritional assessment enables the healthcare professional to further assess energy expenditure and caloric intake for weight management, and to aid in the diagnosis of diseases related to abnormal metabolic parameters. Breezing Med is intended for use with adults breathing normally on their own in a sitting position in a healthcare environment. Since the device is designed for the patient to breathe ambient air, it is not intended for patients where supplementary oxygen is being provided. Breezing Med is not intended to use as sole means for any diagnosis, and ultimately will provide data for evaluation by the professional.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K200076 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200076: Breezing Med.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200076

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026