FDA applicant

Impact Applications, Inc.

San Diego, CA6 decisions2016–20230 recalls

FDA records 6 decisions for Impact Applications, Inc. (San Diego, CA) from 2016 to 2023: 5 510(k) clearances and 1 De Novo grant. All are in product code POM (Computerized Cognitive Assessment Aid For…). Its devices cite 5 predicates, 5 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, neurology panel, where it files most

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

FDA decisions per year

1in 2023

2016high 2 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like Impact Applications, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Impact”

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

Impact Instrumentation, Inc. 27 Impact Medical, LLC 1 Impact Systems Corp. 1 Impact Packaging Corp. 1 Impact Wheelchair Manufacture, Inc. 1 Impact Case Technologies, Inc. 1 Impact Monitors, Inc. 1

Impact Applications, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Impact”