510(k) Report

FDA applicant

Kapp Surgical Instrument, Inc.

Warrensville, OH9 decisions1984–20211 recall

FDA records 9 decisions for Kapp Surgical Instrument, Inc. (Warrensville, OH) from 1984 to 2021: 9 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and HRS (Plate, Fixation, Bone). Its devices cite 5 predicates, 1 of them its own earlier devices. 1 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 Kapp Surgical Instrument, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Kapp Surgical Instrument, Inc.’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?

  • NEUMarker, Radiographic, Implantable2decisions
  • HRSPlate, Fixation, Bone2decisions
  • HTNWasher, Bolt Nut1decision
  • KWIProsthesis, Elbow, Hemi-, Radial, Polymer1decision
  • KXEProsthesis, Wrist, Hemi-, Ulnar1decision
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1decision

Also: GAD (1).

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K050657Mondeal Contour HO SystemKapp Surgical Instrument, Inc. · 20051cites it
  • K050384Kapp Bari-Ring, Model KS-BR-2005Kapp Surgical Instrument, Inc. · 20061cites it
  • K050655Mondeal Radius HO System, Model KS-MR-2005Kapp Surgical Instrument, Inc. · 20051cites it

What has FDA decided for it lately?

  • K200289Michler-Kapp Cardiovascular Vent CatheterKapp Surgical Instrument, Inc. · 2021
  • K072216Kapp Bari-Ring Endoscopic Marker, Model K-9536Kapp Surgical Instrument, Inc. · 20071 recall
  • K050384Kapp Bari-Ring, Model KS-BR-2005Kapp Surgical Instrument, Inc. · 2006
  • K050657Mondeal Contour HO SystemKapp Surgical Instrument, Inc. · 2005
  • K050655Mondeal Radius HO System, Model KS-MR-2005Kapp Surgical Instrument, Inc. · 2005
  • K033930Kapp Custom Ulnar Head Wrist ImplantKapp Surgical Instrument, Inc. · 2004
  • K030237Kapp Custom Radial Head Elbow ImplantKapp Surgical Instrument, Inc. · 2003
  • K844177Cosgrove Mitral Valve RetractorKapp Surgical Instrument, Inc. · 1984

All 9 as Kapp Surgical Instrument, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K072216Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot…May 24, 2011