510(k) Report

FDA applicant

Ritmed, Inc.

Mchenry, IL22 decisions1983–19842 recalls

FDA records 22 decisions for Ritmed, Inc. (Mchenry, IL) from 1983 to 1984: 22 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 2 recalls are 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 Ritmed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ritmed, Inc. since 2007.

Recalls per year

2in 2026

2026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • EFQGauze/Sponge, Internal10decisions
  • GDYGauze/Sponge, Internal, X-Ray Detectable2decisions
  • KKXDrape, Surgical, Antimicrobial2decisions
  • HOZSponge, Ophthalmic1decision
  • GTCAntisera, All Types, Klebsiella Spp.1decision
  • LYASplint, Intranasal Septal1decision

Also: FQA (1), MMK (1), GED (1), FWZ (1), GEI (1).

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.

  • K830264Floret Tonsil & Adenoid SpongesRitmed, Inc. · 19831cites it

What has FDA decided for it lately?

  • K833626Floret Foam Prep SpongeRitmed, Inc. · 1984
  • K832874Isovis Wound ProtectorRitmed, Inc. · 1983
  • K830270Isovis Wound ProtectorRitmed, Inc. · 1983
  • K830261Floret Strung Gauze SpongesRitmed, Inc. · 1983
  • K830266Floret Kittner or K DissectorRitmed, Inc. · 1983
  • K830267Floret Special Gauze SpongesRitmed, Inc. · 1983
  • K830268Floret Cylindrical/Bronchoscopic/LaminRitmed, Inc. · 1983
  • K830264Floret Tonsil & Adenoid SpongesRitmed, Inc. · 1983

All 22 as Ritmed, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K830269Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995CMay 8, 2026Class II
  • K830269Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in…May 8, 2026Class II