Company ยท US
DeRoyal Industries Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2025. Name variants (Inc, Corp, punctuation) are merged.
92510(k) clearances (1 in 12 months)
236recalls (2 in 12 months)
32recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LRO | General Surgery Tray | 193 |
| FMQ | Restraint, Protective | 18 |
| KKX | Drape, Surgical, Antimicrobial | 11 |
| ILO | Pack, Hot Or Cold, Water Circulating | 6 |
| KDD | Kit, Surgical Instrument, Disposable | 6 |
| FLL | Continuous Measurement Thermometer | 4 |
| FMT | Warmer, Infant Radiant | 4 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| KDQ | Bottle, Collection, Vacuum | 4 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 3 |
| KGX | Tape And Bandage, Adhesive | 3 |
| KID | Restraint, Wheelchair, Non-Protective | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 |
| DXQ | Blood Pressure Cuff | 2 |
| EYC | Catheter, Upper Urinary Tract | 2 |
| FPD | Tube, Feeding | 2 |
| FRO | Dressing, Wound, Drug | 2 |
| HIF | Insufflator, Laparoscopic | 2 |
| HOZ | Sponge, Ophthalmic | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2025 | K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory Deroyal Industries, Inc. | OMP |
| Apr 18, 2024 | K230233 | Prospera Spectruum Negative Pressure Wound Therapy System Deroyal Industries, Inc. | OMP |
| Dec 23, 2020 | K200631 | DeRoyal Temperature Monitoring Probe Deroyal Industries, Inc. | FLL |
| Oct 15, 2020 | K200757 | Foley Catheter with Temperature Sensor Deroyal Industries, Inc. | EYC |
| Apr 2, 2020 | K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Deroyal Industries, Inc. | FMT |
| Apr 2, 2020 | K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethosc Deroyal Industries, Inc. | BZT |
| Jan 21, 2020 | K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover Deroyal Industries, Inc. | FMT |
| Apr 4, 2018 | K173072 | Algidex Ag Silver Alginate Wound Dressing Deroyal Industries, Inc. | FRO |
| Aug 17, 2017 | K171475 | DeRoyal Laprador Specimen Retrieval System Deroyal Industries, Inc. | GCJ |
| Mar 25, 2016 | K152978 | DeRoyal Angiography Kits Deroyal Industries, Inc. | DXT |
| Jul 23, 2015 | K142962 | PROTOCOL Incision Dressing Deroyal Industries | FRO |
| Feb 3, 2014 | K131292 | DEROYAL SPINE SPACER SYSTEM Deroyal Industries, Inc. | MAX |
| Oct 3, 2013 | K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST Deroyal Industries, Inc. | GEI |
| Apr 12, 2010 | K090975 | DEROYAL NON-LOCKING BONE FIXATION SYSTEM Deroyal Industries, Inc. | HRS |
| Nov 2, 2009 | K092317 | DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM Deroyal Industries, Inc. | HRS |
| Jun 18, 2003 | K023591 | ULTRA HIGH PRESSURE INJECTOR LINES Deroyal Industries, Inc. | DQO |
| Apr 29, 2003 | K030365 | DEROYAL DRAPES, STERILE, NON-STERILE Deroyal Industries, Inc. | KKX |
| Apr 28, 2003 | K030364 | DEROYAL GOWNS, STERILE, NON-STERILE Deroyal Industries, Inc. | FYA |
| Jul 20, 1999 | K991525 | DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF Deroyal Industries, Inc. | DXQ |
| Nov 30, 1998 | K983750 | DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER Deroyal Industries, Inc. | FMI |
| Aug 11, 1998 | K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER Deroyal Industries, Inc. | OCT |
| Jul 10, 1998 | K974763 | DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA Deroyal Industries, Inc. | HET |
| Feb 26, 1998 | K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS Deroyal Industries, Inc. | IMD |
| Sep 30, 1997 | K972693 | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR Deroyal Industries, Inc. | HOZ |
| May 22, 1997 | K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE Deroyal Industries, Inc. | GEI |
| Feb 13, 1997 | K963466 | PEDIATRIC LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Jan 24, 1997 | K963479 | WHEELCHAIR BELT Deroyal Industries, Inc. | KID |
| Jan 22, 1997 | K963480 | MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER Deroyal Industries, Inc. | KID |
| Jan 22, 1997 | K963476 | DISPOSABLE LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Jan 22, 1997 | K963475 | PONCHO VEST RESTRAINT Deroyal Industries, Inc. | KID |
| Jan 22, 1997 | K963474 | TUXEDO VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Jan 22, 1997 | K963468 | RESTRICTIVE LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Jan 3, 1997 | K963467 | ROLL BELTS Deroyal Industries, Inc. | FMQ |
| Dec 19, 1996 | K963465 | PELVIC HOLDER Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963478 | SLEEVED/SLEEVELESS VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963473 | REUSABLE LIMB HOLDER Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963472 | PEDIATRIC VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963471 | SUPER SECURITY RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963470 | CRISS-CROSS VEST RESTRAINT Deroyal Industries, Inc. | FMQ |
| Nov 14, 1996 | K963469 | MITTENS Deroyal Industries, Inc. | FMQ |
| Nov 12, 1996 | K963477 | PEDIATRIC MITTENS Deroyal Industries, Inc. | FMQ |
| Nov 12, 1996 | K963464 | RESTRAINT NET Deroyal Industries, Inc. | FMQ |
| Oct 16, 1996 | K963463 | STRAIT JACKET Deroyal Industries, Inc. | FMQ |
| Oct 8, 1996 | K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL Deroyal Industries, Inc. | GEI |
| Dec 13, 1995 | K950565 | DEROYAL SURGICAL INSTRUMENT DRAPE Deroyal Industries, Inc. | KKX |
| Oct 6, 1995 | K953403 | DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS Deroyal Industries, Inc. | KMF |
| Oct 6, 1995 | K952775 | DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING Deroyal Industries, Inc. | MGQ |
| Sep 29, 1995 | K953953 | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF Deroyal Industries, Inc. | KCY |
| Sep 28, 1995 | K953952 | DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF Deroyal Industries, Inc. | DXQ |
| Apr 21, 1995 | K951178 | UROLOGICAL CATHETER & ACCESSORIES Deroyal Industries, Inc. | FCM |
Newest 50 of 92.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2026 | DeRoyal Industries Inc REF: 81-030415
Myocardial Probe Non-Pyrogenic , 400 Series Open, Classified |
FLL | K925792 |
| Jun 3, 2026 | DeRoyal Industries Inc DeRoyal Industries Inc.
Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) Open, Classified |
NAC | None listed |
| Mar 5, 2025 | DeRoyal Industries Inc DeRoyal REF 71-C5100NS Tubing, Suction, Connector;
DeRoyal REF 71-C6100NS Tubing, Suction, Connector;
DeRoyal REF 71-C7100NS Tubing, Suction, Connector
Indicated use - Fluid Movement Open, Classified |
GAZ | None listed |
| Feb 14, 2025 | DeRoyal Industries Inc DeRoyal AMG Suction Connector Tubing REF:
71-2083,
71-C506,
71-C510,
71-C512,
71-C520,
Tubing is intended for fluid movement Open, Classified |
BYY | None listed |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 Open, Classified |
FDE | None listed |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06 Open, Classified |
LRO | K842648 |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06 Open, Classified |
LRO | K842648 |
| Nov 5, 2024 | DeRoyal Industries Inc DeRoyal C-SECTION TRACEPACK, REF 89-9338-06 Open, Classified |
KDD | None listed |
| Sep 30, 2024 | DeRoyal Industries Inc DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572 Open, Classified |
LRO | K842648 |
| Mar 29, 2024 | DeRoyal Industries Inc GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART Open, Classified |
LRO | K842648 |
| Oct 16, 2023 | DeRoyal Industries Inc DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit Open, Classified |
LRO | K842648 |
| Jul 3, 2023 | DeRoyal Industries Inc Custom medical procedure packs labeled as:
a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102;
b) CHOLANGIOGRAPHY KIT, REF 89-7322;
c) CATH LAB PACK, REF 89-9183 Open, Classified |
OEQ | None listed |
| Jul 3, 2023 | DeRoyal Industries Inc Custom medical procedure packs labeled as:
a) PELVIC EXAM TRAY, REF 89-6219 Open, Classified |
MLT | None listed |
| Jul 3, 2023 | DeRoyal Industries Inc Custom medical procedure packs labeled as:
a) STANDARD OB PACK ASCENSION WI, REF 89-10640
b) ANGIO PACK, REF 89-10901
c) BASIN, REF 89-1924
d) CYSTO PACK, REF 89-7133
e) TOTAL HIP PACK, REF 89-9134
Open, Classified |
KDD | None listed |
| Jul 3, 2023 | DeRoyal Industries Inc Custom medical procedure packs labeled as:
a) STURDI STRAINER TRAY STANDARD, REF '89-5014 Open, Classified |
FNY | None listed |
| Jul 3, 2023 | DeRoyal Industries Inc Custom medical procedure packs labeled as:
a) OPEN HEART TRACECART, REF '53-1941;
b) CARDIAC CATH PACK, REF '89-10045;
c) SHOULDER PACK, REF '89-10115;
d) MINOR ORTHO PACK, REF '89-10213;
e) T Open, Classified |
LRO | K842648 |
| Jun 7, 2023 | DeRoyal Industries Inc Sterile custom surgical procedure packs
(1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and
(2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital. Open, Classified |
OHM | None listed |
| Jun 7, 2023 | DeRoyal Industries Inc Sterile custom surgical procedure packs:
(1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital;
(2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital;
(3) 89-10509.02, LAPAROTOMY PACK, Stone Open, Classified |
LRO | K842648 |
| Mar 23, 2023 | DeRoyal Industries Inc DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B Open, Classified |
KDQ | None listed |
| Jan 9, 2023 | DeRoyal Industries Inc DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 Terminated |
LRO | K842648 |
| Jan 5, 2023 | DeRoyal Industries Inc DeRoyal Tonsillectomy Tray, REF 89-10698.01 Terminated |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-10086.05 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-10040.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-9241.04 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-9241.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-8859.08 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CATARACT PACK, REF 89-8650.10 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc GEO-MED CATARACT PACK, REF 89-5790.08 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TRACECART POSTEROR LUMBAR FUSION TRACECART, REF 53-1961.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TRACECART SHOULDER ARTHROSCOPY TRACECART, REF 53-1962.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal BIOPSY PACKPACK, REF 89-9756.05 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal PACEMAKER ICD PACK, REF 89-10902.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal NEURO SPINE BACK PACK PGYBK, REF 89-10853.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-10820.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal LAMI/CRANI PACK, REF 89-10787.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal NEURO PACK, REF 89-10682.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal GU PACK, REF 89-10665.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal GU PACK, REF 89-10665.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal LUMBAR DISC PACK, REF 89-10605.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal LUMBAR DISC PACK, REF 89-10590.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CMC POSTERIOR SPINE PACK, REF 89-10570.01 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CARDIAC LINEN PACK, REF 89-10543.02 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CNRV SPINAL PACK, REF 89-10532.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal PAIN TRAY, REF 89-10464.03 Open, Classified |
LRO | None listed |
| Dec 15, 2022 | DeRoyal Industries Inc DeRoyal PAIN TRAY, REF 89-10464.02 Open, Classified |
LRO | None listed |
Newest 50 of 236.