FDA applicant

Kurin, Inc.

San Diego, CA3 decisions2019–20230 recalls

FDA records 3 decisions for Kurin, Inc. (San Diego, CA) from 2019 to 2023: 3 510(k) clearances. All are in product code JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Since 2016 its 510(k)s took a median of 210 days from receipt to decision, against 181 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2023

2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like Kurin, 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

Kurin, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?