510(k) Report

FDA applicant

First Ray, LLC

Logan, UT4 decisions2016–20170 recalls

FDA records 4 decisions for First Ray, LLC (Logan, UT) from 2016 to 2017: 4 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 10 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2017

2016: 32017: 1
2016high 3 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like First Ray, 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?

  • JDRStaple, Fixation, Bone2decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision
  • HWCScrew, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 118 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163440Stealth Staple SystemFirst Ray, LLC · 20172cite it
  • K153622First Ray Internal Bone Staple SystemFirst Ray, LLC · 20162cite it
  • K153585Flip Button Suture AnchorFirst Ray, LLC · 20161cites it

What has FDA decided for it lately?

  • K163440Stealth Staple SystemFirst Ray, LLC · 2017
  • K153585Flip Button Suture AnchorFirst Ray, LLC · 2016
  • K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC · 2016
  • K153622First Ray Internal Bone Staple SystemFirst Ray, LLC · 2016

All 4 as First Ray, LLC →