510(k) · Cleared
ClearedMedgraphics Ultima System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Graphics Corp. · BZL Computer, Oxygen-Uptake
Cleared on Sep 6, 2006 as substantially equivalent to K955432 (Medical Graphics Corp., 1996) after a 78-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.
- Decided
- Sep 6, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- BZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955432 (1996). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955432 CPX, CCM, Cath with 15% CO2Medical Graphics Corp. · 1996
- This deviceK061731 Medgraphics Ultima SystemMedical Graphics Corp. · 2006
- Descendant · cites it directly · 3 of its ownK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- Descendant · 2 generations on · 2 of its ownK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- Descendant · cites it directly · 2 of its ownK070858 Express SeriesMedical Graphics Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK200076 Breezing MedTf Health Co. · 2020
- Descendant · 2 generations on · 0 of its ownK190561 NICU V'02Cosmed Nordic Aps · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007 · cites it directly3descendants
- K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S · 2009 · 2 generations on2descendants
- K070858Express SeriesMedical Graphics Corp. · 2007 · cites it directly2descendants
- K200076Breezing MedTf Health Co. · 2020 · 2 generations on0descendants
- K190561NICU V'02Cosmed Nordic Aps · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955432 | CPX, CCM, Cath with 15% CO2 | Medical Graphics Corp. | 1996 | — |
| 0 (this device) | K061731 | Medgraphics Ultima System | Medical Graphics Corp. | 2006 | — |
| +1 | K071911 | Cardiopulmonary Exercise Testing Option to Innocor | Innovision A/S | 2007 | — |
| +2 | K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including… | Innovision A/S | 2009 | — |
| +1 | K070858 | Express Series | Medical Graphics Corp. | 2007 | — |
| +2 | K200076 | Breezing Med | Tf Health Co. | 2020 | — |
| +2 | K190561 | NICU V'02 | Cosmed Nordic Aps | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 2 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955432 | CPX, CCM, Cath with 15% CO2Summary page 1…Computer Device Class: Class Ila Predicate Device: Medgraphics Desktop Diagnostic System with 15% CO 2 Analyzer, K955432 manufactured by Medical Graphics Corporation, 350 Oak Grove Parkway, St. Paul, MN 55127. Description: The Ultima system… | 1996 |
What descends from it? (6)
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?
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 Ultima system uses the direct measurement of oxygen uptake to objectively and non-invasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program…
Read the full statement (115 words)
The Ultima system uses the direct measurement of oxygen uptake to objectively and non-invasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.
The Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.
The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061731: Medgraphics Ultima System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061731
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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