510(k) Report

FDA applicant

Yukon Medical, LLC

Durham, NC11 decisions2012–20250 recalls

FDA records 11 decisions for Yukon Medical, LLC (Durham, NC) from 2012 to 2025: 11 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 39 days from receipt to decision, against 181 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Yukon Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2025

2012: 32013: 12015: 12017: 32021: 12024: 12025: 1
2012high 3 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Yukon Medical, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yukon Medical, 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?

  • LHISet, I.V. Fluid Transfer8decisions
  • FPASet, Administration, Intravascular2decisions
  • ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 39 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 181 days; 4 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 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.

  • K132863Smartsite VialshieldYukon Medical, LLC · 20131cites it
  • K121182Vialok Non-VentedYukon Medical, LLC · 20121cites it
  • K120799Arisure Neutral ValveYukon Medical, LLC · 20121cites it
  • K171101Closed Male LuerYukon Medical · 20171cites it
  • K151963SmartSite Vented Vial Access DeviceYukon Medical, LLC · 20151cites it
  • K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 20211cites it

What has FDA decided for it lately?

  • K240761Arisure® Closed Male Luer with Spike Adapter (YM060)Yukon Medical, LLC · 2025
  • K243486SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC · 2024
  • K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
  • K172884Arisure Closed Vial AdapterYukon Medical · 2017
  • K172631Arisure Dry SpikeYukon Medical · 2017
  • K171101Closed Male LuerYukon Medical · 2017
  • K151963SmartSite Vented Vial Access DeviceYukon Medical, LLC · 2015
  • K132863Smartsite VialshieldYukon Medical, LLC · 2013

All 8 as Yukon Medical, LLC →All 3 as Yukon Medical →