510(k) · Cleared
ClearedReevue Indirect Calorimeter, Model#8100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Korr Medical Technologies, Inc. · BZL Computer, Oxygen-Uptake
Cleared on Jan 2, 2003 as substantially equivalent to K010577 (Healthetech, Inc., 2002) after a 238-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Jan 2, 2003
- Review
- 238 days
- Class
- Class II
- Product code
- BZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010577 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010577 Bodygem, Model HB211Healthetech, Inc. · 2002
- This deviceK021490 Reevue Indirect Calorimeter, Model#8100Korr Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK190561 NICU V'02Cosmed Nordic Aps · 2020
- Descendant · cites it directly · 0 of its ownK071533 Fitmate SeriesCosmed Srl · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010577 | Bodygem, Model HB211 | Healthetech, Inc. | 2002 | — |
| 0 (this device) | K021490 | Reevue Indirect Calorimeter, Model#8100 | Korr Medical Technologies, Inc. | 2003 | — |
| +1 | K190561 | NICU V'02 | Cosmed Nordic Aps | 2020 | — |
| +1 | K071533 | Fitmate Series | Cosmed Srl | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2020 | 1 | 0 |
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
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.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K190561 (Cosmed Nordic Aps, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All BZL devicesBZL Computer, Oxygen-Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZL
2in 2020
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The REEVUE is intended for use in clinical and research applications to measure oxygen uptake.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021490 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021490: Reevue Indirect Calorimeter, Model#8100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021490
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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