# K210625: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medwork GmbH
- Decided: Sep 10, 2021 after 192 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K001241 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102581: Defendo Disposable Suction Valve Model 100305, Byrne Medical, Inc. (2010) Summary page 4.
- K102409: Defendo Disposable Air/Water Valve Model 100304, Byrne Medical, Inc. (2010) Summary page 4.
- K090851: Defendo (TM) Biopsy Valve for Olympus (R) and Fujinon (R) Endoscopes, Model 100301, Defendo (TM) Biopsy Valve for Pentax (R), Byrne Medical, Inc. (2009) Summary page 4.

## Most influential descendants
- K221264: FROG Forceps Valve (VAL1-F1-100) (2022), 0 descendants of its own

## Indications for use
The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve. The JAZZ Suction Valve is intended to control the suction function (aspiration of air and fluids) of a FUJIFILM gastrointestinal endoscope during endoscopy procedures. The JAZZ Air/Water Valve is intended to control air of a FUJIFILM gastrointestinal endoscope for insufflations and water delivery (for distal lens cleaning) during endoscopy procedures. The JAZZ Forceps Valve is intended to facilitate passage of an endotherapy device, to prevent a leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM gastrointestinal endoscope.

Source page: https://510kreport.com/device/K210625
Methodology: https://510kreport.com/methodology