510(k) Report

FDA applicant

Pro-Safe Professional Linens, Inc.

Grand Junction, CO7 decisions1989–19890 recalls

FDA records 7 decisions for Pro-Safe Professional Linens, Inc. (Grand Junction, CO) in 1989: 7 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and FXO (Suit, Surgical). 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 hospital panel, where it files most

How often FDA has decided Pro-Safe Professional Linens, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pro-Safe Professional Linens, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pro-Safe Professional Linens, 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?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories4decisions
  • FXOSuit, Surgical1decision
  • EAZLight, Operating, Dental1decision
  • FYAGown, Surgical1decision

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.

  • K891212Aprons, Scrubs Slacks & Tops, Patient DrapePro-Safe Professional Linens, Inc. · 19891cites it

What has FDA decided for it lately?

  • K891210Pocketed Wraps #3009 a,B,CPro-Safe Professional Linens, Inc. · 1989
  • K891216Dental Equipment Protection DevicesPro-Safe Professional Linens, Inc. · 1989
  • K891212Aprons, Scrubs Slacks & Tops, Patient DrapePro-Safe Professional Linens, Inc. · 1989
  • K891215Fast Wrap #M 101Pro-Safe Professional Linens, Inc. · 1989
  • K891214Dental Surgical Wrap #3007 a,B,CPro-Safe Professional Linens, Inc. · 1989
  • K891213Surgical Instrument Pouch #M102Pro-Safe Professional Linens, Inc. · 1989
  • K891211Surgical Gown #2001Pro-Safe Professional Linens, Inc. · 1989

All 7 as Pro-Safe Professional Linens, Inc. →