510(k) · Cleared

Cleared

Innocor

K051907510(k) TraditionalCleared Mar 2, 2006231-day reviewClass II21 CFR 870.1425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Innovision A/S · DQK Computer, Diagnostic, Programmable

Cleared on Mar 2, 2006 as substantially equivalent to K872529 (American Edwards Laboratories, 1987) and 6 other predicates after a 231-day review. Its family tree reaches back 6 generations to 1997. 4 later devices descend from it.

Decided: Mar 2, 2006
Review: 231 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 7

Its longest line of descent runs back 6 generations to K962603 (1997). 27 ancestors in all, the oldest K830892 (1983). 4 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
2 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
1 generation backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
This deviceK051907 InnocorInnovision A/S · 2006
Descendant · cites it directly · 3 of its ownK071911 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 4 of 4 · 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 · 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
−6	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−5	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−4	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−3	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
−2	K012451	Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246	Welch Allyn Protocol, Inc.	2001	—
−1	K032363	Zoll M Series Nibp Option	Zoll Medical Corp	2003	—
0 (this device)	K051907	Innocor	Innovision A/S	2006	—
+1	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	2	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	1	0
2011	1	0
2020	1	0

FIG. 1 — Lineage of K051907, 1997–2020Source: 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 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

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What was it cleared against? (8)

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
*	K872529	Thermodilution Cardiac Output Computer, Mod. Com-2 Summary page 1 …ardiac output to two predicate technologies: 1) Thermodilution Cardiac Output Computers (American Edwards Laboratories) K872529 and K830892 and 2) the Direct Fick Method preamendment calculation method.…	American Edwards Laboratories	1987	—
*	K830892	Thermodilution Cardiac Output Computer- Summary page 1 …t to two predicate technologies: 1) Thermodilution Cardiac Output Computers (American Edwards Laboratories) K872529 and K830892 and 2) the Direct Fick Method preamendment calculation method. The pulse oxime…	American Edwards Laboratories	1983	—
*	K970763	Modular Telemetry System (MTS) Option for the Mde Escort II Monitor Summary page 1 …The pulse oximeter component in the Innocor has been shown to be substantially equivalent to the Summary of Substantial N K970763 MITS Option for the ESCORT II Monitor Equivalence (Attachment 1OA) • K982776 Mod…	Medical Data Electronics	1997	—
*	K982776	9303 Neonatal/Adult Vital Signs Monitor Summary page 1 …alent to the Summary of Substantial N K970763 MITS Option for the ESCORT II Monitor Equivalence (Attachment 1OA) • K982776 Model 9303 Neonatal/Adult Vital Signs Monitor (See Attachment 21)) •…	Cas Medical Systems, Inc.	1998	—
*	K021138	Sleepscreen/Apnoescreen Cardio Summary page 1 …• K982776 Model 9303 Neonatal/Adult Vital Signs Monitor (See Attachment 21)) • K021 138 SleepScreen and ApnoeScreen Cardio (Attachment 1OB) The NIBP component…	Erich Jaeger GmbH	2003	—
*	K032363	Zoll M Series Nibp Option Summary page 1 …The NIBP component option in the Innocor has been shown to be substantially equivalent to the * K032363 Zoll M-Series (NIBP Option) • K05 1703 Clever TD-301 8ATM Blood Pressure Monitor…	Zoll Medical Corp	2003	—
*	K051703	Clever TD-3018A Blood Pressure Monitor Cleared while this submission was under review Summary page 1 …en shown to be substantially equivalent to the * K032363 Zoll M-Series (NIBP Option) • K05 1703 Clever TD-301 8ATM Blood Pressure Monitor Innocor is a compact point-of-care device intended to be used…	Taidoc Technology Corporation	2005	—
*	—	Direct Fick Method preamendment calculation method Named without a submission number			—

What descends from it? (4)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071911	Cardiopulmonary Exercise Testing Option to Innocor	Innovision A/S	2007	3
K083879	Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…	Innovision A/S	2009	2
K190561	NICU V'02	Cosmed Nordic Aps	2020	0
K102047	Lci Option for Innocor	Innovision A/S	2011	0

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 9 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
2 of the 27 ancestors have a recall of any class.
Of its descendants, K071911 (Innovision A/S, 2007) has gone furthest, with 3 descendants of its own.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)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?

Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respiration> and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation <95% as measured by a pulse oximeter…

Read the full statement (147 words)

Innocor is indicated for the determination of a number of hemodynamic parameters.

Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respiration> and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation <95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to C0

As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures.

With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters:

* Cardiac Output

* Arterial Oxygen Saturation

* Heart Rate

* Stroke Volume

Lung Volume

* Cardiac Index

* Stroke Index

* Blood Pressures (Systolic, Diastolic, Mean Arterial)

* Systemic Vascular Resistance

Systemic Vascular Resistance Index

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051907 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051907: Innocor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051907

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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