510(k) Report

FDA applicant

Inrad

Kentwood, MI15 decisions1998–20252 recalls

FDA records 15 decisions for Inrad (Kentwood, MI) from 1998 to 2025: 15 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and NEU (Marker, Radiographic, Implantable). Since 2016 its 510(k)s took a median of 268 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Inrad, Inc.”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2025

2007: 12009: 32011: 12019: 12024: 12025: 1
2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2015

2013: 12015: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Inrad by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNWInstrument, Biopsy8decisions
  • NEUMarker, Radiographic, Implantable4decisions
  • GDWStaple, Implantable2decisions
  • LHISet, I.V. Fluid Transfer1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 268 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 178 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 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.

  • K981166Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214Inrad · 19982cite it
  • K993785Ultraclip Tissue MarkerInrad · 20002cite it
  • K090611Revolution Full Core BiopsyInrad · 20092cite it
  • K000612Accucore Single Action Core Biopsy DeviceInrad · 20001cites it
  • K063238Ultraclip II Wing and Ultraclip II CoilInrad · 20071cites it
  • K183503EasyMark Tissue MarkerInrad, Inc. · 20191cites it

What has FDA decided for it lately?

  • K243886ExpressCore Biopsy DeviceInrad, Inc. · 2025
  • K240429Trilogy Tissue MarkerInrad, Inc. · 2024
  • K183503EasyMark Tissue MarkerInrad, Inc. · 2019
  • K112945Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier 18GAX10CM , W/Hiliter 18GAX15CMInrad, Inc. · 20111 recall
  • K093399Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520Inrad · 2009
  • K093256Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018Inrad · 2009
  • K090611Revolution Full Core BiopsyInrad · 2009
  • K063238Ultraclip II Wing and Ultraclip II CoilInrad · 2007

All 11 as Inrad →All 4 as Inrad, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K112945EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15…Apr 24, 2015Class II
  • K993785BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to…Apr 16, 2013Class II