510(k) Report

FDA applicant

Alcresta, Inc.

Newton, MA1 decision2015–20150 recalls

FDA records 1 decision for Alcresta, Inc. (Newton, MA) in 2015: 1 De Novo grant. All are in product code PLQ (Enzyme Packed Cartridge). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Alcresta, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Alcresta, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PLQEnzyme Packed Cartridge1decision

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.

  • DEN150001RelizorbAlcresta, Inc. · 20153cite it

What has FDA decided for it lately?

The one decision as Alcresta, Inc. →

Other applicant names beginning “Alcresta”

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

Alcresta Therapeutics, Inc. 7