510(k) · Cleared
ClearedOrca Cardiopulmonary Exercise Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orca Diagnostics Corp. · BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Cleared on Jul 21, 1998 as substantially equivalent to K923209 (Medical Graphics Corp., 1993) and 1 other predicate after a 253-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jul 21, 1998
- Review
- 253 days
- Class
- Class II
- Product code
- BZM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923209 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK923209 Medgraphics Exercise ConsultMedical Graphics Corp. · 1993
- This deviceK974200 Orca Cardiopulmonary Exercise Testing SystemOrca Diagnostics Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923209 | Medgraphics Exercise Consult | Medical Graphics Corp. | 1993 | — |
| 0 (this device) | K974200 | Orca Cardiopulmonary Exercise Testing System | Orca Diagnostics Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 BZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 | Decided |
|---|---|---|---|
| * | K923209 | Medgraphics Exercise ConsultSummary page 1…Fax 650 969 6114 A. Legally Marketed Predicate Device The ORCA Cardiopulmonary Exercise Testing System is substantially equivalent to the MedGraphics Exercise Consult (K923209) manufactured by Medica! Graphics, Inc, and the Vmax 229 Series, Pulmonary/metabolic System (K942211) manufactured by Sensormedic… | 1993 |
| * | K942211 | VMAX229 Series Pulmonary/Metabolic SystemsSummary page 1…tem is substantially equivalent to the MedGraphics Exercise Consult (K923209) manufactured by Medica! Graphics, Inc, and the Vmax 229 Series, Pulmonary/metabolic System (K942211) manufactured by Sensormedics, Inc., which are both hardware and software devices. The ORCA device 1s substantially equivalent to… | 1994 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All BZM devicesBZM Calculator, Pulmonary Function Interpretor (Diagnostic): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZM
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · BZM
Too few BZM 510(k)s in any year since 2007 to give a median.
Recalls per year · BZM
No recall names BZM since 2007.
Adverse event reports per year · BZM
1in 2007
MAUDE reports naming product code BZM, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 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 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.
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/K974200 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974200: Orca Cardiopulmonary Exercise Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974200
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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