Class Class II
Disposable Endoscope Valve Sets (K220884)
Description
Disposable Endoscope Valve Sets by Sml Med-Tech Solutions Limited, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220884
Clearance Date2023-01-17
Clearance TypeTraditional
Product CodeODC
Regulation Number876.1500
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220884
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Disposable Endoscope Valve Sets (K220884) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valve... | Wilson Instruments (Sha) Co., Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instrument... | 2025 |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instrument... | 2024 |
Trace the full predicate network for K220884
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.