510(k) Report

FDA applicant

Piper Access, LLC

Salt Lake City, UT3 decisions2018–20212 recalls

FDA records 3 decisions for Piper Access, LLC (Salt Lake City, UT) from 2018 to 2021: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and PND (Midline Catheter). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

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 Piper Access, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 12019: 12021: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2026

2022: 1, 1 Class I2026 (partial year): 1, 1 Class I
2018high 1 (2022) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Piper Access, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen1decision
  • PNDMidline Catheter1decision
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K191976Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 20191cites it

What has FDA decided for it lately?

  • K210047Stiletto Extended Dwell CatheterPiper Access, LLC · 2021
  • K191976Piper GO-IO Intraosseous Infusion SystemPiper Access, LLC · 20192 Class I recalls
  • K1819045 FR Dual Lumen Piper PICCPiper Access, LLC · 2018

All 3 as Piper Access, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K191976BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered…Jul 30, 2026Class I
  • K203193Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered…Jun 20, 2022Class I

Other applicant names beginning “Piper”

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

Piper Medical Products 3