510(k) · Cleared
Recalled · Class II · 2016Lci Option for Innocor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovision A/S · BZC Calculator, Pulmonary Function Data
Cleared on Nov 1, 2011 as substantially equivalent to K051907 (Innovision A/S, 2006) and 4 other predicates after a 468-day review. Its family tree reaches back 9 generations to 1997. It has been recalled once.
- Decided
- Nov 1, 2011
- Review
- 468 days
- Class
- Class II
- Product code
- BZC
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 9 generations to K962603 (1997). 44 ancestors in all, the oldest K830892 (1983). No later device cites it as a predicate yet.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK051907 InnocorInnovision A/S · 2006
- 2 generations backK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- 1 generation backK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- This deviceK102047 Lci Option for InnocorInnovision A/S · 2011
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 4 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 3 generations backK051907 InnocorInnovision A/S · 2006
- 2 generations backK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- 1 generation backK083879 Innocor Ergospirometry System (INN00010), the Basic Innocor…Innovision A/S · 2009
- This deviceK102047 Lci Option for InnocorInnovision A/S · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −4 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −3 | K051907 | Innocor | Innovision A/S | 2006 | — |
| −2 | 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 | — |
| 0 (this device) | K102047 | Lci Option for Innocor | Innovision A/S | 2011 | — |
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 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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 BZC? 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 BZC device
- #1 K240293 STSscore 9.8 · 7 generations · no Class I recall
What was it cleared against? (5)
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 2…Page 5.1 of 5.8 5. 51 0(k) Summary LCI Option far Innocor 5 10(k) number: K05 1907 Manufacturer: Innovision A/S, Denmark Predicate Device No. 2 Nam… | 2006 |
| * | K071911 | Cardiopulmonary Exercise Testing Option to InnocorSummary page 2…vision A/S, Denmark Predicate Device No. 2 Name: Cardiopulmonary Exercise Testing Option 5 10(k) number: K071911I Manufacturer: Innovision XIS, Denmark PredicateDevice No. 3 Nam… | 2007 |
| * | K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Summary page 2…Manufacturer: Innovision XIS, Denmark PredicateDevice No. 3 Name: Spirometry Option 5 10(k) number: K083879 Manufacturer: Innovision A/S, Denmark Predicate Device No. 4 Nam… | 2009 |
| * | K001174 | Cosmed QuarkSummary page 2…Manufacturer: Innovision A/S, Denmark Predicate Device No. 4 Name: COSMED QUARK 5 10(k) number: K001 174 Manufacturer: COSMED S.r.l., Italy PredicateDevice No. 5 Name: S… | 2001 |
| * | K942211 | VMAX229 Series Pulmonary/Metabolic SystemsSummary page 2…., Italy PredicateDevice No. 5 Name: SensorMedics Vmax Series Pulmonary/Metabolic System 5 10(k) number: K9422 11 Manufacturer: SensorMedics Device Description Innocor is a compact point-of-care device intended to be us… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2016 | Class II | Z-2769-2016 | Device Design | The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 44 ancestors have a recall of any class.
- 3 other devices also cite its predicate K051907.
How does its category compare?
All BZC devicesBZC Calculator, Pulmonary Function Data: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BZC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZC
Too few BZC 510(k)s in any year since 2007 to give a median.
Recalls per year · BZC
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZC
3in 2025
MAUDE reports naming product code BZC, 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 | 3 |
| 2009 | 0 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LCI Option for Innocor is intended to measure the Lung Clearance Index (LCT), which is the
cumulative expired volume required to clear an inert gas from the lungs during normal breathing
in a multiple-breath washout (MBW) test divided by the Functional Residual Capacity (ERC).
The specific parameters measured by the Innocor LCI Option include:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102047: Lci Option for Innocor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102047
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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