FDA applicant

Meditrina, Inc.

San Jose, CA5 decisions2019–20230 recalls

FDA records 5 decisions for Meditrina, Inc. (San Jose, CA) from 2019 to 2023: 5 510(k) clearances. All are in product code HIH (Hysteroscope (And Accessories)). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2023

2019high 3 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Meditrina, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meditrina, 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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Meditrina, 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?