Data / Medical devices / United States / Deroyal Industries, Inc.
Deroyal Industries, Inc.: FDA-registered device maker in New Tazewell, TN, United States, 141 510(k) clearances
Deroyal Industries, Inc. is registered with the FDA (registration 2320762) in New Tazewell, TN, United States. It lists 203 device types. The FDA files 141 510(k) clearances under its listings, the newest dated March 25, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2320762
- FEI number
- 3003040625
- Address
- 1595 Highway 33 S, New Tazewell, TN, United States, 37825
- Owner or operator
- DEROYAL INDUSTRIES, INC. (1044833)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- July 15, 1991
- Registered through
- 2026
- Brand names listed
- Absorber, Saliva, Paper - DeRoyal, Accessories, Catheter - DeRoyal, Accessories, Operating-Room, Table (Kit) - DeRoyal, Accessory, Surgical Apparel - DeRoyal, Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal, Airway, Oropharyngeal, Anesthesiology - DeRoyal, Amniotome - DeRoyal, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - DeRoyal and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 141.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2024 | K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Sets | DYB | Substantially Equivalent | Cook Medical | accessdata.fda.gov |
| July 29, 2020 | K201361 | PNEUMOCLEAR | HIF | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| March 16, 2020 | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| May 1, 2019 | K183413 | TruWave Disposable Pressure Transducer | DXO | Substantially Equivalent | Edwards Lifeciences, LLC | accessdata.fda.gov |
| October 30, 2018 | K181488 | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier | FZP | Substantially Equivalent | Ethicon Endo-Surgery, LLC | accessdata.fda.gov |
| November 21, 2017 | K170754 | 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing | FRO | Substantially Equivalent | 3M Company, 3M Healthcare | accessdata.fda.gov |
| April 28, 2017 | K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | OMP | Substantially Equivalent | Vr Medical Technologies, LLC | accessdata.fda.gov |
| April 21, 2016 | K152059 | Disposable General Electrode | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| October 22, 2015 | K152096 | DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive | MPN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 21, 2014 | K134006 | DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| August 18, 2014 | K142011 | SOLUTION SET/EXTENSION SET | FPA | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 25, 2014 | K141311 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE | NGT | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| May 23, 2013 | K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | FMG | Substantially Equivalent | Elcam Medical Acal | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 19, 2011 | K111441 | UNIMAX VERESS NEEDLE | HIF | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 25, 2011 | K110699 | LIGAMAX 5 | FZP | Substantially Equivalent | Ethicon Endo-Sugery, LLC | accessdata.fda.gov |
| November 9, 2010 | K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| March 11, 2010 | K092980 | PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 | LKF | Substantially Equivalent | Panpac Medical Corporation | accessdata.fda.gov |
| November 19, 2009 | K092503 | RADAR VASCULAR COMPRESSION DEVICES | DXC | Substantially Equivalent | Advanced Vascular Dynamics | accessdata.fda.gov |
| October 9, 2009 | K091758 | BD SPINAL NEEDLE 27G | BSP | Substantially Equivalent | Becton Dickson & Co. | accessdata.fda.gov |
| September 11, 2009 | K091223 | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 | GEI | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| March 25, 2009 | K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 21, 2008 | K081791 | E-Z CLEAN ELECTROSURGICAL ELECTRODE | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| October 8, 2008 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
| August 12, 2008 | K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS | GEI | Substantially Equivalent | Xodus Medical, Inc. | accessdata.fda.gov |
| June 25, 2008 | K081634 | CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL | GEI | Substantially Equivalent | Conmed Corporation | accessdata.fda.gov |
| December 7, 2007 | K070558 | BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS | EZL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 24, 2007 | K070432 | GENERAL SURGERY DRAPES | KKX | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| July 16, 2007 | K070936 | WELMED HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| May 24, 2007 | K070431 | WELMED, INC. SURGICAL GOWNS | FYA | Substantially Equivalent | Welmed, Inc. | accessdata.fda.gov |
| March 26, 2007 | K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR | EZL | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| September 25, 2006 | K061422 | SURGICAL DRAPES | KKX | Substantially Equivalent | Austin Medical, Inc. | accessdata.fda.gov |
| June 5, 2006 | K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N | FYA | Substantially Equivalent | Cardinal Health 200, Inc. | accessdata.fda.gov |
| April 24, 2006 | K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | DWJ | Substantially Equivalent | Arizant Healthcare, Inc. | accessdata.fda.gov |
| May 6, 2005 | K043036 | NON-STICK ELECTRODE | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| March 9, 2005 | K050292 | SHARPOINT LUKENS BONE WAX | MTJ | Substantially Equivalent | Surgical Specialties Corp | accessdata.fda.gov |
| November 30, 2004 | K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | MMP | Substantially Equivalent | Guangzhou Fortunique , Ltd. | accessdata.fda.gov |
| July 28, 2004 | K041399 | HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE | FMI | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| May 14, 2004 | K041071 | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 | JKA | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| May 13, 2004 | K033003 | SUCTION COAGULATOR | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| October 30, 2003 | K032676 | ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR | GCJ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| September 10, 2003 | K031287 | STERI-DRAPE SURGICAL DRAPES | KKX | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| January 27, 2003 | K023254 | SPEEDICATH | GBM | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| December 17, 2002 | K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 7, 2002 | K022159 | PISTON SYRINGE & HYPODERMIC NEEDLE | FMF | Substantially Equivalent | International Medsurg Connection | accessdata.fda.gov |
| October 26, 2001 | K003229 | BIOPATCH ANTIMICROBIAL DRESSING | SEL | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| October 25, 2001 | K012736 | MONOJECT SAFETY NEEDLE | FMI | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| September 18, 2001 | K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | KKX | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
| August 22, 2001 | K011941 | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 | FRO | Substantially Equivalent | The Kendall Company | accessdata.fda.gov |
| August 1, 2001 | K012128 | PROTECTIV ACUVANCE IV CATHETER SYSTEM | FOZ | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| July 7, 2000 | K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | DXZ | Substantially Equivalent | Bridger Biomed, Inc. | accessdata.fda.gov |
| June 7, 2000 | K992221 | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | FRO | Substantially Equivalent | Westaim Biomedical, Inc. | accessdata.fda.gov |
| February 10, 1999 | K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| August 11, 1998 | K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | OCT | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| July 13, 1998 | K981582 | SURGILON, DERMALON, & OPHTHALON | GAR | Substantially Equivalent | Davis & Geck, Inc. | accessdata.fda.gov |
| July 10, 1998 | K981393 | MICROCOOL SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 9, 1998 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| February 3, 1998 | K974553 | 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130) | GEI | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| June 24, 1997 | K970855 | CLAVE CONNECTOR | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| June 17, 1997 | K971449 | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) | GIM | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| May 22, 1997 | K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE | GEI | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| April 2, 1997 | K964435 | PRIMARY IV SET | FMG | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| January 24, 1997 | K965054 | PENCIL | GEI | Substantially Equivalent | Megadyne Medical Products, Inc. | accessdata.fda.gov |
| October 9, 1996 | K962886 | ANESTHESIA CONDUCTION NEEDLE | BSP | Substantially Equivalent | Ispg, Inc. | accessdata.fda.gov |
| October 8, 1996 | K962042 | GLASS SYRINGE | FMF | Substantially Equivalent | Ispg, Inc. | accessdata.fda.gov |
| October 8, 1996 | K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL | GEI | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| September 3, 1996 | K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | GEI | Substantially Equivalent | Unimed Surgical Products, Inc. | accessdata.fda.gov |
| July 31, 1996 | K952030 | LOOP/SQUARE ELECTRODE | HGI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| June 21, 1996 | K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 15, 1996 | K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 | GCJ | Substantially Equivalent | Davol Inc., Sub. C. R. Bard, Inc. | accessdata.fda.gov |
| May 14, 1996 | K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | LJH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 3, 1996 | K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | LIO | Substantially Equivalent | Starplex Scientific, Inc. | accessdata.fda.gov |
| February 1, 1996 | K955836 | VALLEYLAB COATED ELECTRODES | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 6, 1995 | K941258 | LATEX CONDOM | HIS | Substantially Equivalent | Suretex, Ltd. | accessdata.fda.gov |
| October 7, 1995 | K953418 | ELECTROCAUTERY SHROUD | GCJ | Substantially Equivalent | I.C Medical, Inc. | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| August 1, 1995 | K950429 | VIDEO SIGMOIDOSCOPE | FAM | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 14, 1995 | K942988 | FILTERED EXTENSION SETS | FPA | Substantially Equivalent | B. Braun of America, Inc. | accessdata.fda.gov |
| May 5, 1995 | K944265 | NEEDLE ELCTRODE | GEI | Substantially Equivalent | Unimed Surgical Products, Inc. | accessdata.fda.gov |
| April 18, 1995 | K950301 | ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| March 1, 1995 | K945715 | MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES | FMF | Substantially Equivalent | Sherwood Medical Co. | accessdata.fda.gov |
| February 10, 1995 | K945531 | BLADE ELECTRODE | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| December 27, 1994 | K946044 | DISPOSABLE GAS SAMPLING LINES | CCK | Substantially Equivalent | Catheter Research, Inc. | accessdata.fda.gov |
| December 21, 1994 | K935985 | DEROYAL CRITICAL CARE DISPOSABLE WASTE STATION | DQO | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| November 17, 1994 | K943508 | INSUFFLATOR TUBING WITH FILTER | HET | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| May 2, 1994 | K940299 | ELECTROSURGICAL DISPERSIVE ELECTRODE AND ELECTROSURGICAL DUAL RETURN ELECTRODE WITH CONDUCTIVE GEL AND 10 FT. CORD | GEI | Substantially Equivalent | Debusk Technology Corp. | accessdata.fda.gov |
| March 30, 1994 | K940909 | ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE | GEI | Substantially Equivalent | Debusk Technology Corp. | accessdata.fda.gov |
| February 25, 1994 | K925791 | EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR | FLL | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| January 12, 1994 | K935835 | BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES | BYX | Substantially Equivalent | Busse Hospital Disposables, Inc. | accessdata.fda.gov |
| December 16, 1993 | K931202 | STERILIZATION WRAP-STERISHEET | FRG | Substantially Equivalent | Arjo Wiggins Medical, Inc. | accessdata.fda.gov |
| July 20, 1993 | K924721 | BAXTER SOLUTION ADMINISTRATION SETS | FPA | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| April 29, 1993 | K923127 | NEEDLE-PRO CARTRIDGE | FMI | Substantially Equivalent | Concord/Portex | accessdata.fda.gov |
| February 1, 1993 | K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | GCI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| August 24, 1992 | K922492 | SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER | CAH | Substantially Equivalent | Specialty Packaging Producs, Inc. | accessdata.fda.gov |
| July 24, 1992 | K920135 | MEDROYAL ANGIOGRAPHIC CONTROL SYRINGE | DXT | Substantially Equivalent | Medroyal, Inc. | accessdata.fda.gov |
| February 12, 1992 | K914118 | I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR | FYD | Substantially Equivalent | I.C Medical, Inc. | accessdata.fda.gov |
| September 18, 1991 | K912614 | ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS | GEI | Substantially Equivalent | Andrew Surgical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 17, 2013 | 66742 | Class II | Terminated | Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy. | The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock. | accessdata.fda.gov |
| November 22, 2004 | 30701 | Not yet classified | Terminated | Cold Therapy Blanket | There is a possibility of water leaking from the welded seam of the blanket. | accessdata.fda.gov |
| January 19, 2004 | 28270 | Not yet classified | Terminated | Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box | Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed. | accessdata.fda.gov |
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Updated March 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.