FDA applicant

Nanoentek USA, Inc.

Pleasanton, CA5 decisions2014–20170 recalls

FDA records 5 decisions for Nanoentek USA, Inc. (Pleasanton, CA) from 2014 to 2017: 5 510(k) clearances. Most are in product codes LTJ (Prostate-Specific Antigen (Psa) For Management…) and CEC (Radioimmunoassay, Free Thyroxine). Its devices cite 5 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 Nanoentek USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2014high 2 (2016) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Nanoentek USA, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nanoentek USA, 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 “Nanoentek”

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

Nanoentek, Inc. 1

Nanoentek USA, 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 “Nanoentek”