FDA applicant

Accutome, Inc.

Malvern, PA8 decisions1981–20150 recalls

FDA records 8 decisions for Accutome, Inc. (Malvern, PA) from 1981 to 2015: 8 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and HKY (Tonometer, Manual). Its devices cite 12 predicates, 2 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, radiology panel, where it files most

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

FDA decisions per year

1in 2015

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Accutome, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Accutome, 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 “Accutome”

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

Accutome Ultrasound, Inc. 3 Accutome, Inc. Doing Business AS Keeler USA 1

Accutome, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Accutome”