510(k) · Cleared
Recalled · Class II · 2020Andorate Auxiliary Water Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartdata Suzhou Co., Ltd. · OCX Endoscopic Irrigation/Suction System
Cleared on Apr 17, 2019 after a 169-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled 11 times.
- Decided
- Apr 17, 2019
- Review
- 169 days
- Class
- Class II
- Product code
- OCX
- Recalls
- 11
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK182998 Andorate Auxiliary Water ConnectorSmartdata Suzhou Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK230932 ANDORATE® Valve KitGa Health Company Limited · 2023
Most influential descendants
Showing 1 of 1 · See all- K230932ANDORATE® Valve KitGa Health Company Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K182998 | Andorate Auxiliary Water Connector | Smartdata Suzhou Co., Ltd. | 2019 | — |
| +1 | K230932 | ANDORATE® Valve Kit | Ga Health Company Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCX device
- #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230932 | ANDORATE® Valve Kit | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2020 | Class II | Z-0639-2021 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K230932 (Ga Health Company Limited, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OCX devicesOCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OCX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCX
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCX
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCX
33in 2025
MAUDE reports naming product code OCX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 51 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 256 | 0 | 1 |
| 2013 | 3 | 106 | 0 | 1 |
| 2014 | 6 | 77 | 0 | 5 |
| 2015 | 2 | — | 1 | 9 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 5 | 60 | 0 | 18 |
| 2019 | 8 | 133 | 0 | 41 |
| 2020 | 4 | 88 | 11 | 11 |
| 2021 | 3 | 233 | 0 | 8 |
| 2022 | 6 | 84 | 2 | 18 |
| 2023 | 7 | 109 | 0 | 46 |
| 2024 | 4 | 74 | 0 | 21 |
| 2025 | 4 | 178 | 0 | 33 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K182998 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182998: Andorate Auxiliary Water Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182998
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026