510(k) Report

FDA applicant

Asante Solutions, Inc.

Sunnyvale, CA2 decisions2013–20140 recalls

FDA records 2 decisions for Asante Solutions, Inc. (Sunnyvale, CA) from 2013 to 2014: 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. 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 Asante Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2013: 12014: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Asante Solutions, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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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:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122483Pearl Diabetes Management SystemAsante Solutions, Inc. · 20131cites it

What has FDA decided for it lately?

  • K142619Snap Insulin Pump SystemAsante Solutions, Inc. · 2014
  • K122483Pearl Diabetes Management SystemAsante Solutions, Inc. · 2013

All 2 as Asante Solutions, Inc. →