510(k) · Cleared

Cleared

Fitmate Series

K071533510(k) TraditionalCleared Sep 28, 2007115-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

Cosmed Srl · BZL Computer, Oxygen-Uptake

Cleared on Sep 28, 2007 as substantially equivalent to K021490 (Korr Medical Technologies, Inc., 2003) and 1 other predicate after a 115-day review. Its family tree reaches back 2 generations to 2002.

Decided: Sep 28, 2007
Review: 115 days
Class: Class II
Product code: BZL
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K010577 (2002). 3 ancestors in all, the oldest K001174 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010577 Bodygem, Model HB211Healthetech, Inc. · 2002
1 generation backK021490 Reevue Indirect Calorimeter, Model#8100Korr Medical Technologies, Inc. · 2003
This deviceK071533 Fitmate SeriesCosmed Srl · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010577	Bodygem, Model HB211	Healthetech, Inc.	2002	—
−1	K021490	Reevue Indirect Calorimeter, Model#8100	Korr Medical Technologies, Inc.	2003	—
0 (this device)	K071533	Fitmate Series	Cosmed Srl	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K071533, 2002–2007Source: 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
#2 Held for the reportin the report

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What was it cleared against? (2)

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
*	K021490	Reevue Indirect Calorimeter, Model#8100 Summary page 2 …Code: BZL Classification Panel: AN SUBSTANTIAL EQUIVALENT: The COSMED Fitmate is similar to the Reevue Indirect Calorimeter, Model # 8100 (K021490) manufactured by Korr Medical Technologies, Inc., 3090 East 3300 South, Suite 100, Salt Lake City, UT 84109, USA and the Quark pu…	Korr Medical Technologies, Inc.	2003	—
*	K001174	Cosmed Quark Summary page 2 …K021490) manufactured by Korr Medical Technologies, Inc., 3090 East 3300 South, Suite 100, Salt Lake City, UT 84109, USA and the Quark pulmonary function testing system (K001174) manufactured by COSMED srl, 37 Via dei Piani di Monte Savello Pavona di Albano Laziale (Rome) 00040 Italy. All three systems ar…	Cosmed Srl	2001	—

Also cleared against K021490: 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 5 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K021490.

How does its category compare?

All BZL devices

BZL Computer, Oxygen-Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071533 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071533: Fitmate Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071533

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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