# K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500)

- Pathway: 510(k) (Traditional)
- Applicant: Innovision A/S
- Decided: Feb 23, 2009 after 56 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 41 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051907: Innocor, Innovision A/S (2006) Summary page 1.
- K071911: Cardiopulmonary Exercise Testing Option to Innocor, Innovision A/S (2007) Summary page 1.
- K072979: Spirobank G, Mir Medical Intl. Research Srl (2007) Summary page 2.

## Most influential descendants
- K190561: NICU V'02 (2020), 0 descendants of its own
- K102047: Lci Option for Innocor (2011), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K083879
Methodology: https://510kreport.com/methodology