510(k) Report

FDA applicant

Acrymed, Inc.

Portland, OR14 decisions1994–20091 recall

FDA records 14 decisions for Acrymed, Inc. (Portland, OR) from 1994 to 2009: 14 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…). Its devices cite 1 predicate, 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, general hospital panel, where it files most

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

FDA decisions per year

2in 2009

2007: 12008: 12009: 2
2007high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2008

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

Class I Class II/III not classified

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

Planning a device like Acrymed, Inc.’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?

  • FRODressing, Wound, Drug9decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic3decisions
  • KMFBandage, Liquid2decisions

Who builds on its devices?

Later devices cite its devices 24 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.

  • K011994Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Acrymed, Inc. · 200112cite it
  • K083103Acryderm Antimicrobial Silver Gel Wound Dressing Model #BAcrymed, Inc. · 20095cite it
  • K070333Acryderm Silver Antimicrobial Otc Wound GelAcrymed, Inc. · 20072cite it
  • K002599Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045Acrymed, Inc. · 20002cite it
  • K943781Acryderm Advanced Wound DressingAcrymed, Inc. · 19941cites it
  • K991818Acryderm Silver Anti-Microbial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045Acrymed, Inc. · 20001cites it

What has FDA decided for it lately?

  • K091354Acryderm Silver Antimicrobial Foam Wound DressingAcrymed, Inc. · 2009
  • K083103Acryderm Antimicrobial Silver Gel Wound Dressing Model #BAcrymed, Inc. · 2009
  • K082459Acryderm Absorbent Oxygen DressingAcrymed, Inc. · 2008
  • K070333Acryderm Silver Antimicrobial Otc Wound GelAcrymed, Inc. · 2007
  • K061232Acryderm Silver Antimicrobial Thin Film, Model 2006Acrymed, Inc. · 20061 recall
  • K011994Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Acrymed, Inc. · 2001
  • K012116Acryderm Silver Antimicrobial Perforated Wound DressingAcrymed, Inc. · 2001
  • K002909Acryderm Silver Antimicrobial Strands Model a-020103Acrymed, Inc. · 2000

All 14 as Acrymed, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061232ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is…Jun 30, 2008