Data / Medical devices / United States / DeRoyal Industries, Inc.
DeRoyal Industries, Inc.: FDA-registered device maker in New Tazewell, TN, United States, 69 510(k) clearances
DeRoyal Industries, Inc. is registered with the FDA (registration 1060680) in New Tazewell, TN, United States. It lists 134 device types. The FDA files 69 510(k) clearances under its listings, the newest dated September 6, 2019. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1060680
- FEI number
- 1000208624
- Address
- 1703 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
- April 3, 1991
- Registered through
- 2026
- Brand names listed
- Accessories, Cleaning Brushes, for Endoscope - DeRoyal, Accessories, Operating-Room, Table (Kit) - DeRoyal, Accessory Surgical Apparel - DeRoyal, Accessory, Surgical Apparel - DeRoyal, Adaptor, Dressing - DeRoyal, Adaptor, Grooming - DeRoyal, Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal, Aid, Transfer - 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2019 | K182751 | Reusable Temperature Probe | FLL | Substantially Equivalent | Shenzhen Caremed Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 16, 2017 | K170338 | A-View | ITX | Substantially Equivalent | Stroke2prevent B.V. | 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 20, 2015 | K150160 | Temple Touch Pro (TTP) Non-invasive temperature monitoring system | FLL | Substantially Equivalent | Medisim, Ltd. | accessdata.fda.gov |
| November 21, 2014 | K134006 | DISPOSABLE LAPAROSCOPIC ELECTRODE, DISPOSABLE LAPAROSCOPIC ELECTRODE | GEI | Substantially Equivalent | Modern Medical Equipment Manufacturing Limited | accessdata.fda.gov |
| October 3, 2013 | K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST | GEI | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| August 22, 2013 | K130027 | DISPOSABLE NEUTRAL ELECTRODE GP202 | GEI | Substantially Equivalent | Cathay Manufacturing Corp. | accessdata.fda.gov |
| January 5, 2012 | K112458 | PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM | OMP | Substantially Equivalent | Medica-Rents Co., Ltd. | accessdata.fda.gov |
| August 19, 2011 | K111441 | UNIMAX VERESS NEEDLE | HIF | Substantially Equivalent | Unimax Medical Systems, Inc. | accessdata.fda.gov |
| June 10, 2011 | K103736 | DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE | FMF | Substantially Equivalent | Dmc Medical, Ltd. | accessdata.fda.gov |
| May 20, 2011 | K102946 | CORELEADER COLLA-PAD MODEL CS 03030 | KGN | Substantially Equivalent | Coreleader Biotech Co., Ltd. | accessdata.fda.gov |
| March 3, 2011 | K093830 | MEDLINE ANGIOGRAPHIC CONTROL SYRINGE | DXT | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| December 13, 2010 | K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES | FPD | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| November 8, 2010 | K102073 | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS | FPA | Substantially Equivalent | Benlan, Inc. | accessdata.fda.gov |
| July 1, 2010 | K101669 | THERMODILUTION CATHETER | DQO | Substantially Equivalent | Biosensors Intl. Pte. , Ltd. | accessdata.fda.gov |
| June 3, 2010 | K094056 | HOTDOG MULTI FUNCTION CONTROLLER | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| January 7, 2010 | K093349 | MEDLINE CURAD WOUND DRESSINGS | FRO | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| December 10, 2009 | K092807 | HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| September 11, 2009 | K091223 | VALLEYLAB SUCTION COAGULATOR, MODEL E3305 | GEI | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| August 12, 2008 | K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS | GEI | Substantially Equivalent | Xodus Medical, Inc. | accessdata.fda.gov |
| February 7, 2008 | K073438 | PROSTIM 1000/2000 | GZJ | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
| May 4, 2006 | K052392 | HOT DOG PATIENT WARMING SYSTEM | DWJ | Substantially Equivalent | Augustine Biomedical & Design, LLC | accessdata.fda.gov |
| May 6, 2005 | K043036 | NON-STICK ELECTRODE | GEI | Substantially Equivalent | Modern Medical Equipment Mfg., Ltd. | accessdata.fda.gov |
| April 18, 2005 | K042449 | DOLPHIN INFLATION DEVICE | MAV | Substantially Equivalent | Sedat S.A. | accessdata.fda.gov |
| November 12, 2004 | K041967 | GENICON SUCTION IRRIGATION SYSTEM | GCJ | Substantially Equivalent | Genicon | accessdata.fda.gov |
| September 3, 2004 | K042301 | PROTENS ELECTRODE | GXY | Substantially Equivalent | Bio Protech, 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 |
| March 3, 2004 | K032840 | ATRION MEDICAL QL INFLATION DEVICE | KOE | Substantially Equivalent | Atrion Medical Products, Inc. | accessdata.fda.gov |
| March 7, 2003 | K030339 | CAUTERY TIP CLEANER, MODEL-TC-100 | GEI | Substantially Equivalent | Aspen Surgical Products, Inc. | accessdata.fda.gov |
| December 17, 2002 | K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 19, 2002 | K022841 | ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 | GZJ | Substantially Equivalent | Biomedical Life Systems, Inc. | accessdata.fda.gov |
| November 15, 2002 | K011618 | CALGITROL AG SILVER ALGINATE WOUND DRESSING | FRO | Substantially Equivalent | Adri | accessdata.fda.gov |
| June 13, 2002 | K020753 | DEROYAL SURGICAL, UMBILICUP | KSR | Substantially Equivalent | Deroyal | accessdata.fda.gov |
| September 7, 2000 | K001872 | I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 | FPA | Substantially Equivalent | Codan US Corp. | accessdata.fda.gov |
| June 20, 2000 | K993625 | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 | HIF | Substantially Equivalent | Genicon, LC | accessdata.fda.gov |
| February 4, 2000 | K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | HAM | Substantially Equivalent | Nikomed U.S.A., Inc. | accessdata.fda.gov |
| August 12, 1999 | K992363 | SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN | FRO | Substantially Equivalent | Euromed, Inc. | accessdata.fda.gov |
| February 10, 1999 | K984276 | DISPOSABLE ELECTROSURGERY GROUNDING PAD | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| February 4, 1999 | K982472 | GENICON TROCAR | GEA | Substantially Equivalent | Genicon, LC | accessdata.fda.gov |
| August 11, 1998 | K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | OCT | Substantially Equivalent | Deroyal Industries, Inc. | accessdata.fda.gov |
| July 9, 1998 | K981956 | DEGANIA SILICONE IDENTI LOOPS | DXC | Substantially Equivalent | Degania Silicone , Ltd. | accessdata.fda.gov |
| December 15, 1997 | K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | FRO | Substantially Equivalent for Some Indications | Kendall Healthcare Products Co. Div.Of Tyco Health | accessdata.fda.gov |
| October 8, 1997 | K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | DXT | Substantially Equivalent | Coeur Laboratories, Inc. | accessdata.fda.gov |
| December 23, 1996 | K960492 | SI CONTROLLER MODEL SI 500 | BTA | Substantially Equivalent | I.C Medical, Inc. | accessdata.fda.gov |
| September 12, 1996 | K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | DXT | Substantially Equivalent | Coeur Laboratories, 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 |
| July 25, 1995 | K944450 | SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE | HGI | Substantially Equivalent | Unimed Surgical Products, Inc. | accessdata.fda.gov |
| May 5, 1995 | K944265 | NEEDLE ELCTRODE | GEI | Substantially Equivalent | Unimed Surgical Products, Inc. | accessdata.fda.gov |
| February 10, 1995 | K945531 | BLADE ELECTRODE | GEI | Substantially Equivalent | E & M Engineering, Inc. | accessdata.fda.gov |
| July 19, 1994 | K941932 | SPLASH MASK | LYU | Substantially Equivalent | Incon Diversified Industries, Inc. | 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 28, 1994 | K934969 | DUALGARD FACE SHIELD | FXX | Substantially Equivalent | White Knight Healthcare | 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 20, 1991 | K905073 | CARDIOVASCULAR REPAIR PATCH | DXZ | Substantially Equivalent | Impra, Inc. | accessdata.fda.gov |
| September 18, 1991 | K912614 | ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS | GEI | Substantially Equivalent | Andrew Surgical | accessdata.fda.gov |
| August 7, 1991 | K912132 | OPERAND LUBRICATING JELLY | FHX | Substantially Equivalent | General Medical Co. | accessdata.fda.gov |
| November 25, 1988 | K884656 | DISPOSABLE BIPOLAR CORD AND BIPOLAR FORCEP | GEI | Substantially Equivalent | Dermacare | accessdata.fda.gov |
| August 10, 1988 | K883094 | MX350 (SERIES) CONTROL SYRINGE | FMF | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| March 2, 1988 | K880402 | CODMAN SURGICAL PATTIE | HBA | Substantially Equivalent | Codman & Shurtleff, Inc. | accessdata.fda.gov |
| March 15, 1986 | K850960 | NON-ABSORBENT DRAPES & ABSORBENT TOWELS | KKX | Substantially Equivalent | Excel Health Care Products | accessdata.fda.gov |
| July 11, 1985 | K851834 | MANAN GWI GUIDE WIRE INTRODUCER | DWS | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| February 18, 1983 | K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | DXT | Substantially Equivalent | Coeur Laboratories, Inc. | accessdata.fda.gov |
| September 21, 1982 | K822572 | POLYHESIVE PATIENT RETURN ELECTRODE | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 10, 1981 | K813071 | E2508 DISPOSABLE HANDSWITCHING PENCIL | GEI | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| November 5, 1979 | K791871 | NEUROLOGICAL SPONGES (PATTIES) | EFQ | Substantially Equivalent | Carwild Corp. | accessdata.fda.gov |
| February 22, 1979 | K782168 | 3-WAY STOPCOCK | FMG | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 10, 2012 | 61038 | Not yet classified | Terminated | Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufa | The firm distributed surgical kits which contained DermaHook Neuro Elastic Retractors which were subsequently recalled by Teleflex. | accessdata.fda.gov |
| February 7, 2011 | 58148 | Not yet classified | Terminated | Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; (2) DeRoyal(R) Water Soluble | Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies. | accessdata.fda.gov |
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Updated September 6, 2019. 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.