510(k) Report

FDA applicant

Deroyal

Powell, TN5 decisions2002–20042 recalls

FDA records 5 decisions for Deroyal (Powell, TN) from 2002 to 2004: 5 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and EYC (Catheter, Upper Urinary Tract). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Deroyal’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Deroyal since 2007.

Recalls per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Deroyal 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?

  • FYAGown, Surgical2decisions
  • EYCCatheter, Upper Urinary Tract1decision
  • KKXDrape, Surgical, Antimicrobial1decision
  • KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components1decision

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 2 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.

  • K041416Exac-Temp Foley Catheter and Clini-Temp Foley CatheterDeroyal · 20042cite it

What has FDA decided for it lately?

  • K041416Exac-Temp Foley Catheter and Clini-Temp Foley CatheterDeroyal · 2004
  • K033057Deroyal Surgical Gowns, Sterile, Non-SterileDeroyal · 2003
  • K031408Deroyal Poly-Reinforced Surgical Gowns (Sterile, Non-Sterile)Deroyal · 2003
  • K030908Deroyal Surgical Drapes Backtable CoverDeroyal · 2003
  • K020753Deroyal Surgical, UmbilicupDeroyal · 20022 recalls

All 5 as Deroyal →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K020753DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN 37849…Jan 20, 2012
  • K020753DeRoyal (R) Umbilicup, REF 72-8000, Rx Only, STERILE EO, Manufactured by DeRoyal…Jan 20, 2012

Other applicant names beginning “Deroyal”

FDA records each applicant name separately; these may or may not be the same firm.

Deroyal Industries, Inc. 92Deroyal Critical Care, Div. Deroyal Technologies 1Deroyal Surgical 1Deroyal Cardiovascular, Inc. 1