FDA applicant

Konica Minolta Healthcare Americas, Inc.

Garner, NC6 decisions2020–20260 recalls

FDA records 6 decisions for Konica Minolta Healthcare Americas, Inc. (Garner, NC) from 2020 to 2026: 6 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 42 days from receipt to decision, against 46 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Konica Minolta Healthcare Americas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2022

2020high 3 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Konica Minolta Healthcare Americas, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Konica Minolta Healthcare Americas, 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 “Konica”

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

Konica Minolta Medical & Graphic, Inc. 27 Konica Minolta, Inc. 25 Konica Medical Corp. 12 Konica Corp. 5 Konica Minolta Sensing, Inc. 3 Konica Medical and Graphic Corporation 1 Konica Minolta Technoproduct Co., Ltd. 1

Konica Minolta Healthcare Americas, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Konica”