510(k) Report

FDA applicant

Evermed, Inc.

Walker, MI9 decisions1983–20024 recalls

FDA records 9 decisions for Evermed, Inc. (Walker, MI) from 1983 to 2002: 9 510(k) clearances. Most are in product codes LJS (Catheter, Intravascular, Therapeutic…) and IOR (Wheelchair, Mechanical). Its devices cite 3 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Evermed Corp.”.

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 Evermed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Evermed, Inc. since 2007.

Recalls per year

1in 2025

2013: 22023: 12025: 1
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Evermed, 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?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days4decisions
  • IORWheelchair, Mechanical2decisions
  • DRCTrocar1decision
  • FKXSystem, Peritoneal, Automatic Delivery1decision
  • ITIWheelchair, Powered1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K830256Non-Sterile Broviac Parenteral Alimi-Evermed, Inc. · 19831cites it
  • K830233Non-Sterile,Single/Souble Lumen-CathEvermed, Inc. · 19831cites it
  • K023485Explorer Powered WheelchairEvermed Corp. · 20021cites it

What has FDA decided for it lately?

  • K023993Galaxy Series WheelchairEvermed Corp. · 2002
  • K024030Millennium Series Manual WheelchairsEvermed Corp. · 2002
  • K023485Explorer Powered WheelchairEvermed Corp. · 2002
  • K840846Sterile Hichman/Broviac Injection CapEvermed, Inc. · 1984
  • K840529Steiger Tunneling Instrument 285Evermed, Inc. · 1984
  • K830256Non-Sterile Broviac Parenteral Alimi-Evermed, Inc. · 19831 recall
  • K830406Non-Sterile Catheter Repair KitsEvermed, Inc. · 19831 recall
  • K830233Non-Sterile,Single/Souble Lumen-CathEvermed, Inc. · 19833 recalls

All 6 as Evermed, Inc. →All 3 as Evermed Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K830233Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff…Dec 12, 2025Class II
  • K830406Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610…Jan 4, 2023Class II
  • K830233Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with…Feb 21, 2013Class II
  • K830233Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with…Feb 21, 2013Class II