510(k) Report

FDA applicant

Valeritas, LLC

Shrewsbury, MA2 decisions2010–20115 recalls

FDA records 2 decisions for Valeritas, LLC (Shrewsbury, MA) from 2010 to 2011: 2 510(k) clearances. All are in product code LZG (Pump, Infusion, Insulin). Its devices cite 2 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Valeritas, Inc.”.

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

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

5in 2019

2019: 5
2010high 5 (2019) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Valeritas, LLC by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Valeritas, 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?

  • LZGPump, Infusion, Insulin2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K100504V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40Valeritas, LLC · 20101cites it
  • K103825V-GO Insulin Delivery SystemValeritas, Inc. · 20111cites it

What has FDA decided for it lately?

  • K103825V-GO Insulin Delivery SystemValeritas, Inc. · 20115 recalls
  • K100504V-GO Disposable Insulin Delivery Device, Model# V-GO 20, V-GO 30, V-GO40Valeritas, LLC · 2010

The one decision as Valeritas, LLC →The one decision as Valeritas, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K103825DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03Jul 3, 2019Class II
  • K103825DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02Jul 3, 2019Class II
  • K103825DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02Jul 3, 2019Class II
  • K103825DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01Jul 3, 2019Class II
  • K103825DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03Jul 3, 2019Class II