510(k) · Cleared
ClearedCardiopulmonary Exercise Testing Option to Innocor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovision A/S · DQK Computer, Diagnostic, Programmable
Cleared on Sep 7, 2007 as substantially equivalent to K051907 (Innovision A/S, 2006) and 1 other predicate after a 58-day review. Its family tree reaches back 7 generations to 1997. 3 later devices descend from it.
- Decided
- Sep 7, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K962603 (1997). 30 ancestors in all, the oldest K830892 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 2 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 1 generation backK051907 InnocorInnovision A/S · 2006
- This deviceK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- Descendant · cites it directly · 2 of its ownK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- Descendant · cites it directly · 0 of its ownK190561 NICU V'02Cosmed Nordic Aps · 2020
- Descendant · cites it directly · 0 of its ownK102047 Lci Option for InnocorInnovision A/S · 2011 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S · 2009 · cites it directly2descendants
- K190561NICU V'02Cosmed Nordic Aps · 2020 · cites it directly0descendants
- K102047Lci Option for InnocorInnovision A/S · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −2 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −1 | K051907 | Innocor | Innovision A/S | 2006 | — |
| 0 (this device) | K071911 | Cardiopulmonary Exercise Testing Option to Innocor | Innovision A/S | 2007 | — |
| +1 | K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including… | Innovision A/S | 2009 | — |
| +1 | K190561 | NICU V'02 | Cosmed Nordic Aps | 2020 | — |
| +1 | K102047 | Lci Option for Innocor | Innovision A/S | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K051907 | InnocorSummary page 1…System," and "BbB System") Common Name Cardiopulmonary Exercise Testing System Classification [Hemodynamic Measurements-Already ClearedK051907] Computer, diagnostic, programmable Regulation Number: 21 CFR §870.1425… | 2006 |
| * | K061731 | Medgraphics Ultima SystemSummary page 2…Manufacturer: Innovision A/S, Denmark PredicateDevice No. 2 Name: Ultima System 510(k) number: K061731 Manufacturer: Medical Graphics Corporation, MN Device Description Innocor is a compact point-of-care devic… | 2006 |
What descends from it? (3)
3 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?
- The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 30 ancestors have a recall of any class.
- Of its descendants, K083879 (Innovision A/S, 2009) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K051907.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for: Main metabolic…
Read the full statement (156 words)
A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for:
Main metabolic parameters:
* Oxygen uptake
* Carbon dioxide excretion
* Expiratory minute ventilatidn
Calculated/derived parameters:
* Oxygen uptake per kg
* Respiratory exchange ratio
* Alveolar ventilation
* Anatomical dead space (Fowler dead space)
* Tidal volume
* Respiratory rate
* End-tidal concentration of oxygen
* End-tidal concentration of carbon dioxide
* Expiratory quotient / ventilatory equivalent for oxygen
* Expiratory quotient / ventilatory equivalent for carbon dioxide
And the following calculated parameters after an incremental exercise test:
* Anaerobic threshold
* Respiratory compensation
* Rest values
* Values at AT point
* Values at max exercise
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071911: Cardiopulmonary Exercise Testing Option to Innocor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071911
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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