# K022276: Kokomate

- Pathway: 510(k) (Abbreviated)
- Applicant: Ferraris Respiratory, Inc.
- Decided: Oct 4, 2002 after 81 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: 3 generations back to K896120 (1990). 5 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982995: Accutrax, Model EPF840, Korr Medical Technologies, Inc. (1998) Summary page 1.
- K992823: Spirovit SP-2, Pneumocheck II, Schiller AG (2000) Summary page 1.

## Most influential descendants
- 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
- K142812: Vitalograph Model 6800 Pneumotrac (2015), 1 descendant of its own

## Indications for use
KoKoMate is a diagnostic spirometer for use in the pnmary-care setting to measure and report the following spirometric values: Peak Expiratory Flow, One-Second (FEVI) and Six-Second (FEVG) Forced Expiratory Volumes, Forced Expiratory Flow averaged from 25 - 75% of total volume, and the ratio of FEVl/FEVG.

Source page: https://510kreport.com/device/K022276
Methodology: https://510kreport.com/methodology