FDA applicant

Pathway, LLC

Santee, CA3 decisions2016–20200 recalls

FDA records 3 decisions for Pathway, LLC (Santee, CA) from 2016 to 2020: 3 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Pathway, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Pathway, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pathway, LLC’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 “Pathway”

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

Pathway Medical Technologies, Inc. 16 Pathway Products, Inc. 1

Pathway, LLC

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 “Pathway”