510(k) Report

FDA applicant

Avitar, Inc.

Canton, MA4 decisions1990–19970 recalls

FDA records 4 decisions for Avitar, Inc. (Canton, MA) from 1990 to 1997: 4 510(k) clearances. Most are in product codes JOH (Tube Tracheostomy And Tube Cuff) and NAC (Dressing, Wound, Hydrophilic). No 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Avitar, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avitar, 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?

  • JOHTube Tracheostomy And Tube Cuff1decision
  • NACDressing, Wound, Hydrophilic1decision
  • NADDressing, Wound, Occlusive1decision
  • MGPDressing, Wound And Burn, Occlusive1decision

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.

  • K973260Hydrasorb Sterile DressingAvitar, Inc. · 19971cites it

What has FDA decided for it lately?

  • K973260Hydrasorb Sterile DressingAvitar, Inc. · 1997
  • K925841Hydrasorb Joyce SpongeAvitar, Inc. · 1993
  • K897102Hydrasorb (TM)Avitar, Inc. · 1990
  • K897156Hydrasorb (TM)Avitar, Inc. · 1990

All 4 as Avitar, Inc. →