510(k) Report

FDA applicant

Procyte Corp.

Kirkland, WA9 decisions1996–19981 recall

FDA records 9 decisions for Procyte Corp. (Kirkland, WA) from 1996 to 1998: 9 510(k) clearances. Most are in product codes MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…) and KMF (Bandage, Liquid). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Procyte Corp. since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Procyte Corp.’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?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic5decisions
  • KMFBandage, Liquid4decisions

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.

  • K964468Iamin Wet Dressing (Copper-Saline)Procyte Corp. · 19971cites it

What has FDA decided for it lately?

  • K971612Osmo/Pca Pillow Wound DressingProcyte Corp. · 1998
  • K972150Osmocyte Island Wound DressingProcyte Corp. · 1997
  • K972329Osmocyte RA Wound DressingProcyte Corp. · 1997
  • K970153Lamin-2 Hydrating GelProcyte Corp. · 1997
  • K965143Osmocyte Wound Manager Sheet DressingProcyte Corp. · 1997
  • K965005Iamin Impregnated Gauze DressingProcyte Corp. · 1997
  • K964468Iamin Wet Dressing (Copper-Saline)Procyte Corp. · 19971 recall
  • K962623Osmocyte Ultra/PE Pillow Wound DressingProcyte Corp. · 1996

All 9 as Procyte Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K953853Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on…Mar 26, 2015Class II