510(k) · Cleared
ClearedInnocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovision A/S · BZG Spirometer, Diagnostic
Cleared on Feb 23, 2009 as substantially equivalent to K051907 (Innovision A/S, 2006) and 2 other predicates after a 56-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 23, 2009
- Review
- 56 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K962603 (1997). 41 ancestors in all, the oldest K830892 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 6 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 5 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 4 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 3 generations backK032363 Zoll M Series Nibp OptionZoll Medical Corp · 2003
- 2 generations backK051907 InnocorInnovision A/S · 2006
- 1 generation backK071911 Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S · 2007
- This deviceK083879 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −7 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −6 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −5 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −4 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −3 | K032363 | Zoll M Series Nibp Option | Zoll Medical Corp | 2003 | — |
| −2 | K051907 | Innocor | Innovision A/S | 2006 | — |
| −1 | K071911 | Cardiopulmonary Exercise Testing Option to Innocor | Innovision A/S | 2007 | — |
| 0 (this device) | 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 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…ovision.dk Device Name Spirometry Option to Innocor Common Name Diagnostic Spirometer Classification [Hemodynamic Measurements-Already Cleared K05190 7] Computer, diagnostic, programmable Regulation Number: 21 CFR §870.1425… | 2006 |
| * | K071911 | Cardiopulmonary Exercise Testing Option to InnocorSummary page 1…Panel Code: Cardiovascular Device Class: Ila [Cardiopulmonary Exercise Testing Option -Already Cleared K0719111 Oxygen uptake computer Regulation Number: 21 CFR §868.1730 Produc… | 2007 |
| * | K072979 | Spirobank GSummary page 2…Manufacturer: Innovision A/S, Denmark PredicateDevice No. 3 Name: Spirobank G 510(k) number: K072979 Manufacturer: MIR Medical International Research Device Description Innocor is a compact point-of-care de… | 2007 |
What descends from it? (2)
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?
- The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K190561 (Cosmed Nordic Aps, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K051907.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Spirometry Option for Innocor is intended to be used as a diagnostic spirometer, used in pulmonary function testing, to measure the flow of gas moving into and out of a patient's lungs. In order to produce data regarding the maximum performance with respect to tidal volume and ventilation, the specific parameters measured by the Innocor Spirometry Option are: FEV 1 — Forced expiratory volume in one second — L [BTPS] FVC — Forced vital capacity — L…
Read the full statement (200 words)
The Spirometry Option for Innocor is intended to be used as a diagnostic spirometer, used in pulmonary function testing, to measure the flow of gas moving into and out of a patient's lungs.
In order to produce data regarding the maximum performance with respect to tidal volume and ventilation, the specific parameters measured by the Innocor Spirometry Option are:
FEV 1 — Forced expiratory volume in one second — L [BTPS]
FVC — Forced vital capacity — L [BTPS]
FEVI% — FEV 1 / FVC — %
PEF — Peak expiratory flow — 1/sec [BTPS]
MEF 75* — Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired — 1/sec [BTPS]
MEF 50* — Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired — 1/sec [BTPS]
MEF 25* — Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired — 1/sec [BTPS]
FET — Forced expiratory time — Sec
MVV — Maximum voluntary ventilation — L/min [BTPS]
*MEF 75 is equal to FEF25 (maximal instantaneousforced expiratoryflow where 25% of the FVC has been expired); MEF 50 is equal to FEF50; MEF 25 is equal to FEF 75.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083879
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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