FDA applicant

Accutome, Inc. Doing Business AS Keeler USA

Malvern, PA1 decision2025–20250 recalls

FDA records 1 decision for Accutome, Inc. Doing Business AS Keeler USA (Malvern, PA) in 2025: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 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. Doing Business AS Keeler USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Accutome, Inc. Doing Business AS Keeler USA by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Accutome”

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

Accutome, Inc. 8 Accutome Ultrasound, Inc. 3

Accutome, Inc. Doing Business AS Keeler USA

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Accutome”