510(k) Report

FDA applicant

Sandstone Medical (Suzhou), Inc.

Suzhou, CN3 decisions2021–20260 recalls

FDA records 3 decisions for Sandstone Medical (Suzhou), Inc. (Suzhou, CN) from 2021 to 2026: 3 510(k) clearances. All are in product code FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 331 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Sandstone Medical (Suzhou), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 12022: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Sandstone Medical (Suzhou), Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sandstone Medical (Suzhou), Inc.’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?

  • FMINeedle, Hypodermic, Single Lumen3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 331 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 143 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc. · 20221cites it
  • K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 20211cites it

What has FDA decided for it lately?

  • K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro…Sandstone Medical (Suzhou), Inc. · 2026
  • K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc. · 2022
  • K193422Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc. · 2021

All 3 as Sandstone Medical (Suzhou), Inc. →

Other applicant names beginning “Sandstone”

FDA records each applicant name separately; these may or may not be the same firm.

Sandstone Medical Technologies, LLC 11Sandstone Diagnostics, Inc. 2