# K992823: Spirovit SP-2, Pneumocheck II

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: May 12, 2000 after 263 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: 2 generations back to K896120 (1990). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984031: Spirovit, Model SP-250, Schiller AG (1999) Summary page 1.

## Most influential descendants
- K022276: Kokomate (2002), 8 descendants of its own
- K051572: Koko Legend (2005), 7 descendants of its own
- K100687: Vitalograph Hand Held Spirometer, Model 2120 (2010), 6 descendants of its own
- K200550: Vitalograph Model 2120 In2itive eDiary (2020), 2 descendants of its own
- K212938: Vitalograph Model 6000 Alpha (2022), 1 descendant of its own

## Indications for use
The Spirovit SP-2 / PneumoCheck ® 1 can be used to measure the following spirometric parameters within the Healthcare Facility: Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV 10/ FVC, FEF ¢.1.2, FEF 25.75%, FEF 75.85%, PEF, FEF 255, FEF 500, FEF 759, FIVC, FIV 10, FIV 16/ FIVC, PIF, FiF 50, SVC, ERV, IRV, TV, MVV, MV, RR, TV, in patients 6 years of age or older.

Source page: https://510kreport.com/device/K992823
Methodology: https://510kreport.com/methodology