FDA applicant

Pentax Medical of America, Inc.

Montvale, NJ2 decisions2018–20180 recalls

FDA records 2 decisions for Pentax Medical of America, Inc. (Montvale, NJ) in 2018: 2 510(k) clearances. Most are in product codes FDS (Gastroscope And Accessories, Flexible/Rigid) and FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 2 predicates, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Pentax Medical of America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Pentax Medical of America, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pentax Medical of America, 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 “Pentax”

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

Pentax Precision Instrument Corp. 67 Pentax of America, Inc. 44 Pentax Medical Company 18 Pentax Medical, A Division of Pentax of America, Inc. 2 Pentax Corp. 1

Pentax Medical of America, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Pentax”