510(k) Report

FDA applicant

Deroyal Industries, Inc.

Powell, TN92 decisions1984–202544 recalls

FDA records 92 decisions for Deroyal Industries, Inc. (Powell, TN) from 1984 to 2025: 92 510(k) clearances. Most are in product codes FMQ (Restraint, Protective) and KKX (Drape, Surgical, Antimicrobial). Since 2016 its 510(k)s took a median of 227 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 5 of them its own earlier devices. 44 recalls are linked to its devices, 3 Class I.

FDA’s records also spell it “Deroyal Industries”.

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

FDA decisions per year

1in 2025

2009: 12010: 12013: 12014: 12015: 12016: 12017: 12018: 12020: 52024: 12025: 1
2007high 5 (2020) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2012: 12014: 12015: 12016: 22017: 32018: 12019: 22020: 102021: 5, 2 Class I2022: 42023: 42024: 3, 1 Class I2026 (partial year): 1
2007high 10 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Deroyal Industries, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FMQRestraint, Protective15decisions
  • KKXDrape, Surgical, Antimicrobial11decisions
  • KGXTape And Bandage, Adhesive3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • KIDRestraint, Wheelchair, Non-Protective3decisions
  • FLLContinuous Measurement Thermometer3decisions

Also: FMT (3), BZT (3), GCJ (3), MDM (2), EYC (2), DQO (2).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 227 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 177 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 35 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 5 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.

  • K925006Hydro-Temp Nicu and Skin Surface Temperature SensoDeroyal Industries, Inc. · 19943cite it
  • K925792Exac-Temp & Clini-Temp Tympanic & Myocardial ProbeDeroyal Industries, Inc. · 19942cite it
  • K982465Deroyal Industries, Inc. DefoggerDeroyal Industries, Inc. · 19982cite it
  • K910657Qualtex Island DressingDeroyal Industries, Inc. · 19912cite it
  • K925791Exac-Temp & Clini-Temp Probe W/Temperature SensorDeroyal Industries, Inc. · 19942cite it
  • K023591Ultra High Pressure Injector LinesDeroyal Industries, Inc. · 20032cite it

What has FDA decided for it lately?

  • K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam AccessoryDeroyal Industries, Inc. · 2025
  • K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc. · 2024
  • K200631DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc. · 2020
  • K200757Foley Catheter with Temperature SensorDeroyal Industries, Inc. · 2020
  • K193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French…Deroyal Industries, Inc. · 2020
  • K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor…Deroyal Industries, Inc. · 2020
  • K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc. · 2020
  • K173072Algidex Ag Silver Alginate Wound DressingDeroyal Industries, Inc. · 2018

All 91 as Deroyal Industries, Inc. →The one decision as Deroyal Industries →

What has been recalled?

44 recalls linked to its devices; the latest:

  • K925792REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesAug 20, 2026Class II
  • K842648DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06Oct 3, 2024Class II
  • K842648DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06Oct 3, 2024Class II
  • K842648GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b)…Feb 13, 2024Class I
  • K842648DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572Nov 22, 2023Class II
  • K842648DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kitSep 18, 2023Class II

Other applicant names beginning “Deroyal”

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

Deroyal 5Deroyal Critical Care, Div. Deroyal Technologies 1Deroyal Surgical 1Deroyal Cardiovascular, Inc. 1