510(k) Report

FDA applicant

Vesco Medical, LLC

Columbus, OH5 decisions2017–20230 recalls

FDA records 5 decisions for Vesco Medical, LLC (Columbus, OH) from 2017 to 2023: 5 510(k) clearances. Most are in product codes PIF (Gastrointestinal Tubes With Enteral Specific…) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 260 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Vesco Medical”.

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 Vesco Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2017: 22020: 12023: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Vesco Medical, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vesco Medical, LLC’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?

  • PIFGastrointestinal Tubes With Enteral Specific Connectors3decisions
  • FMFSyringe, Piston1decision
  • LZHPump, Infusion, Enteral1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 260 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 170 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K170218Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 20173cite it

What has FDA decided for it lately?

  • K230326ENFit to ENFit Extension SetsVesco Medical · 2023
  • K232205Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm…Vesco Medical, LLC · 2023
  • K192991Vesco Medical Extension Feeding SetVesco Medical, LLC · 2020
  • K170162Vesco Medical Nasoenteric Feeding TubesVesco Medical, LLC · 2017
  • K170218Vesco Medical NRFit Tip SyringesVesco Medical, LLC · 2017

All 4 as Vesco Medical, LLC →The one decision as Vesco Medical →