510(k) Report

FDA applicant

Cp Medical

Portland, OR32 decisions1982–201811 recalls

FDA records 32 decisions for Cp Medical (Portland, OR) from 1982 to 2018: 32 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). Its devices cite 25 predicates, 10 of them its own earlier devices. 11 recalls are linked to its devices.

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

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2018

2007: 22010: 12018: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2019

2007: 32008: 12009: 22011: 12014: 12017: 12019: 2
2007high 3 (2007) · low 0 (2010)2026

Class I Class II/III not classified

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

Planning a device like Cp Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KXKSource, Brachytherapy, Radionuclide6decisions
  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid3decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene3decisions
  • NEWSuture, Surgical, Absorbable, Polydioxanone2decisions
  • KOCAccessories, Blood Circuit, Hemodialysis2decisions
  • MTJWax, Bone2decisions

Also: FPA (1), GAP (1), GAL (1), GAQ (1), FIB (1), KGX (1).

Whose devices does it build on?

Its devices cite 25 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 10 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.

  • K024372CP Medical Bone WaxCp Medical · 20036cite it
  • K010621Accu-Space Absorbable Seeding SpacersCp Medical · 20015cite it
  • K001172Polyester Nonabsorbable Surgical Sutures UrpCp Medical · 20004cite it
  • K001173Nylon, Nonabsorbable Surgical Sutures UspCp Medical · 20004cite it
  • K041894OrthofiberCp Medical · 20044cite it
  • K013274Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,SterileCp Medical · 20013cite it

What has FDA decided for it lately?

  • K173922C-PTFETM Surgical SutureCp Medical, Inc. · 2018
  • K094028CP-Fiber (Orthofiber)Cp Medical · 2010
  • K072229MonoswiftCp Medical · 20071 recall
  • K071550Pre-Waxed Needles with Gold Fiduciary MarkersCp Medical · 2007
  • K060987OSCERA7 Synthetic Absorbable Bone Wax, Model OS31Cp Medical · 2006
  • K041894OrthofiberCp Medical · 2004
  • K034062CP Sleeve and River SleeveCp Medical · 2004
  • K024372CP Medical Bone WaxCp Medical · 2003

All 31 as Cp Medical →The one decision as Cp Medical, Inc. →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K002190Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm)…Oct 18, 2019Class II
  • K001299Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product…Feb 4, 2019Class II
  • K072229PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical…Feb 2, 2017Class II
  • K030786Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size…Apr 23, 2014Class II
  • K001173Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with…Jun 29, 2011
  • K013274Product is a synthetic absorbable suture with needle and labeled as sterile. The product…Jan 2, 2009