510(k) Report

FDA applicant

Jointvue, LLC

Knoxville, TN3 decisions2017–20210 recalls

FDA records 3 decisions for Jointvue, LLC (Knoxville, TN) from 2017 to 2021: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 24 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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, radiology panel, where it files most

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

FDA decisions per year

1in 2021

2017: 22021: 1
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Jointvue, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 24 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K1725133D EchoJointvue, LLC · 20171cites it

What has FDA decided for it lately?

  • K2116563D Echo v1.1Jointvue, LLC · 2021
  • K173329jFit Surgical PlannerJointvue, LLC · 2017
  • K1725133D EchoJointvue, LLC · 2017

All 3 as Jointvue, LLC →