FDA applicant

Alcresta Therapeutics, Inc.

Waltham, MA7 decisions2016–20250 recalls

FDA records 7 decisions for Alcresta Therapeutics, Inc. (Waltham, MA) from 2016 to 2025: 7 510(k) clearances. All are in product code PLQ (Enzyme Packed Cartridge). Its devices cite 10 predicates, 7 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

2in 2025

2016high 2 (2023) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Alcresta Therapeutics, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alcresta Therapeutics, 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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Other applicant names beginning “Alcresta”

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

Alcresta, Inc. 1

Alcresta Therapeutics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Alcresta”