510(k) Report

FDA applicant

Apn Health, LLC

Pleasanton, CA1 decision2016–20161 recall

FDA records 1 decision for Apn Health, LLC (Pleasanton, CA) in 2016: 1 510(k) clearance. All are in product code DQK (Computer, Diagnostic, Programmable). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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 Apn Health, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2016high 1 (2023) · low 0 (2016)2026

Class I Class II/III not classified

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

Planning a device like Apn Health, LLC’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

Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K152160Navik 3DApn Health, LLC · 20161 recall

The one decision as Apn Health, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K152160Navik 3D v2, REF NAVIK3D, 3D Mapping SystemNov 7, 2023Class III