# K984031: Spirovit, Model SP-250

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Apr 30, 1999 after 169 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: 1 generation back to K896120 (1990). 1 ancestor in all.
10 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)
- K896120: Schiller Model SP-100 Spirovit (TM), Schiller America, Inc. (1990) Summary page 1.

## Most influential descendants
- K992823: Spirovit SP-2, Pneumocheck II (2000), 9 descendants of its own
- 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

## Indications for use
The Spirovit SP-250 can be used to measure Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV, (/JFVC, FEF 4,5, FEF 3759, FEF;545 PEF, FEF 5, FEFep, FEF sy, FIVC, FIV, JFIVC, PIF, FIF,,,, SVC, ERV, IRV, TV, MWV, MV, RR and TV, in patients 6 years of age or older.

Source page: https://510kreport.com/device/K984031
Methodology: https://510kreport.com/methodology