FDA applicant

Mercator Medsystems, Inc.

Emeryville, CA5 decisions2006–20210 recalls

FDA records 5 decisions for Mercator Medsystems, Inc. (Emeryville, CA) from 2006 to 2021: 5 510(k) clearances. Most are in product codes KRA (Catheter, Continuous Flush) and EOQ (Bronchoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 9 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2021

2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mercator Medsystems, 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 “Mercator”

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

Mercator Medical (Thailand), Ltd. 7 Mercator Healthcare, Ltd. 1

Mercator Medsystems, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Mercator”