# Deroyal Industries, Inc.

- Location (FDA's records): Powell, TN
- FDA decisions: 92 (1984–2025): 92 510(k) clearances
- Names in FDA's records: Deroyal Industries, Inc. (91); Deroyal Industries (1)
- Product codes: FMQ (15), KKX (11), KGX (3), GEI (3), KID (3), FLL (3), FMT (3), BZT (3), GCJ (3), MDM (2), EYC (2), DQO (2)
- 510(k) review time since 2016: median 227 days, against 177 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 35 (5 its own); citations of its devices by later devices: 25 (5 its own)
- Recalls linked to its devices: 44 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kci USA, Inc.: 4 (https://510kreport.com/company/kci-usa)
- United States Surgical, A Division of Tyco Healthc: 4 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Adri: 3 (https://510kreport.com/company/adri)
- Ethicon Endo-Surgery, Inc.: 2 (https://510kreport.com/company/ethicon-endo-surgery)
- Spinal Elements, Inc.: 2 (https://510kreport.com/company/spinal-elements)
- Debusk Technology Corp.: 1 (https://510kreport.com/company/debusk-technology)
- Deroyal: 1 (https://510kreport.com/company/deroyal)
- Smith and Nephew Medical Limited: 1 (https://510kreport.com/company/smith-and-nephew-medical)

## Firms that cite its devices most
- GE Healthcare: 4 (https://510kreport.com/company/ge-healthcare)
- Intl. Medsurg Connection, Inc.: 2 (https://510kreport.com/company/intl-medsurg-connection)
- Argentum International, LLC: 2 (https://510kreport.com/company/argentum-international)
- Shenzhen Envisen Industry Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-envisen-industry)
- Shenzhen Med-Link Electronics Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-med-link-electronics-tech)
- Minimally Invasive Devices, LLC: 1 (https://510kreport.com/company/minimally-invasive-devices)
- New Wave Surgical Corporation: 1 (https://510kreport.com/company/new-wave-surgical)
- Kepler Medtec: 1 (https://510kreport.com/company/kepler-medtec)

## Its most-cited devices
- K925006: Hydro-Temp Nicu and Skin Surface Temperature Senso (1994), cited by 3
- K925792: Exac-Temp & Clini-Temp Tympanic & Myocardial Probe (1994), cited by 2
- K982465: Deroyal Industries, Inc. Defogger (1998), cited by 2
- K910657: Qualtex Island Dressing (1991), cited by 2
- K925791: Exac-Temp & Clini-Temp Probe W/Temperature Sensor (1994), cited by 2
- K023591: Ultra High Pressure Injector Lines (2003), cited by 2

## Recent decisions
- K250586: Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (Nov 21, 2025)
- K230233: Prospera Spectruum Negative Pressure Wound Therapy System (Apr 18, 2024)
- K200631: DeRoyal Temperature Monitoring Probe (Dec 23, 2020)
- K200757: Foley Catheter with Temperature Sensor (Oct 15, 2020)
- K193027: Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French (Apr 2, 2020)
- K200319: HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable (Apr 2, 2020)
- K191425: Hydro-Temp Neonatal Skin Temperature Probe Cover (Jan 21, 2020)
- K173072: Algidex Ag Silver Alginate Wound  Dressing (Apr 4, 2018)

Source page: https://510kreport.com/company/deroyal-industries