510(k) Report

FDA applicant

Evans Medical, Inc.

Pineville, PA4 decisions1994–20021 recall

FDA records 4 decisions for Evans Medical, Inc. (Pineville, PA) from 1994 to 2002: 4 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FPK (Tubing, Fluid Delivery). Its devices cite 1 predicate, 0 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 Evans Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Evans Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Evans Medical, 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?

  • FPASet, Administration, Intravascular1decision
  • FPKTubing, Fluid Delivery1decision
  • FMINeedle, Hypodermic, Single Lumen1decision
  • FPBFilter, Infusion Line1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K020530Evans Sub-Q, Model MC4206Evans Medical, Inc. · 20026cite it

What has FDA decided for it lately?

  • K020530Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
  • K935642Evans Medical Extension SetsEvans Medical, Inc. · 19941 recall
  • K935480Medical Specialties Non-Coring Needle Admin SetsEvans Medical, Inc. · 1994
  • K9356410.2. Micron Filter Sets and 1.2 Micron Filter SetsEvans Medical, Inc. · 1994

All 4 as Evans Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K935642Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only *…Mar 15, 2006