# K181509: Endorate Valve Sets

- Pathway: 510(k) (Traditional)
- Applicant: Smartdata Suzhou Co., Ltd.
- Decided: Jul 6, 2018 after 28 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K230932: ANDORATE® Valve Kit (2023), 0 descendants of its own
- K192258: Disposable Valve Sets (2019), 0 descendants of its own

## Recalls of this device
- Nov 3, 2020 · Class II · Z-0639-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0642-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0643-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0640-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0644-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0645-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0647-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0649-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0641-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0646-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- Nov 3, 2020 · Class II · Z-0648-2021: Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Source page: https://510kreport.com/device/K181509
Methodology: https://510kreport.com/methodology