510(k) Report

FDA applicant

Smartdata Suzhou Co., Ltd.

Suzhou, CN4 decisions2018–201911 recalls

FDA records 4 decisions for Smartdata Suzhou Co., Ltd. (Suzhou, CN) from 2018 to 2019: 4 510(k) clearances. Most are in product codes OCX (Endoscopic Irrigation/Suction System) and ODC (Endoscope Channel Accessory). Since 2016 its 510(k)s took a median of 69 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. 11 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Smartdata Suzhou Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2019

2018: 12019: 3
2018high 3 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

11in 2020

2020: 11
2018high 11 (2020) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Smartdata Suzhou Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Smartdata Suzhou Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OCXEndoscopic Irrigation/Suction System3decisions
  • ODCEndoscope Channel Accessory1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 69 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K181509Endorate Valve SetsSmartdata Suzhou Co., Ltd. · 20182cite it
  • K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd. · 20191cites it
  • K191366Vacutore Air/Water Bottle TubingSmartdata Suzhou Co., Ltd. · 20191cites it
  • K182998Andorate Auxiliary Water ConnectorSmartdata Suzhou Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K191366Vacutore Air/Water Bottle TubingSmartdata Suzhou Co., Ltd. · 2019
  • K191231Andorate Auxiliary Water Connector, Andorate Valves SetSmartdata Suzhou Co., Ltd. · 2019
  • K182998Andorate Auxiliary Water ConnectorSmartdata Suzhou Co., Ltd. · 201911 recalls
  • K181509Endorate Valve SetsSmartdata Suzhou Co., Ltd. · 201811 recalls

All 4 as Smartdata Suzhou Co., Ltd. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K181509STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R…Nov 3, 2020Class II
  • K181509STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101…Nov 3, 2020Class II
  • K181509Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and…Nov 3, 2020Class II
  • K181509STOPCON Disposable Valves Set-Single Use Valves…Nov 3, 2020Class II
  • K181509Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and…Nov 3, 2020Class II
  • K181509Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter…Nov 3, 2020Class II