Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Deroyal Industries, Inc. — Predicate Candidate Screening
91 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
273 days90th percentile
91clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foa | Deroyal Industries, Inc. | 2025-11-21 | 267 | 0 |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | 2024-04-18 | 447 | 0 |
| K200631 | DeRoyal Temperature Monitoring Probe | Deroyal Industries, Inc. | 2020-12-23 | 288 | 0 |
| K200757 | Foley Catheter with Temperature Sensor | Deroyal Industries, Inc. | 2020-10-15 | 205 | 0 |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 F | Deroyal Industries, Inc. | 2020-04-02 | 155 | 0 |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-T | Deroyal Industries, Inc. | 2020-04-02 | 55 | 0 |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | Deroyal Industries, Inc. | 2020-01-21 | 237 | 0 |
| K173072 | Algidex Ag Silver Alginate Wound Dressing | Deroyal Industries, Inc. | 2018-04-04 | 187 | 0 |
| K171475 | DeRoyal Laprador Specimen Retrieval System | Deroyal Industries, Inc. | 2017-08-17 | 90 | 0 |
| K152978 | DeRoyal Angiography Kits | Deroyal Industries, Inc. | 2016-03-25 | 168 | 0 |
| K131292 | DEROYAL SPINE SPACER SYSTEM | Deroyal Industries, Inc. | 2014-02-03 | 273 | 0 |
| K132199 | DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER | Deroyal Industries, Inc. | 2013-10-03 | 79 | 0 |
| K090975 | DEROYAL NON-LOCKING BONE FIXATION SYSTEM | Deroyal Industries, Inc. | 2010-04-12 | 371 | 0 |
| K092317 | DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM | Deroyal Industries, Inc. | 2009-11-02 | 90 | 0 |
| K023591 | ULTRA HIGH PRESSURE INJECTOR LINES | Deroyal Industries, Inc. | 2003-06-18 | 236 | 0 |
| K030365 | DEROYAL DRAPES, STERILE, NON-STERILE | Deroyal Industries, Inc. | 2003-04-29 | 84 | 6 |
| K030364 | DEROYAL GOWNS, STERILE, NON-STERILE | Deroyal Industries, Inc. | 2003-04-28 | 83 | 0 |
| K991525 | DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF | Deroyal Industries, Inc. | 1999-07-20 | 78 | 0 |
| K983750 | DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINE | Deroyal Industries, Inc. | 1998-11-30 | 38 | 0 |
| K982465 | DEROYAL INDUSTRIES, INC. DEFOGGER | Deroyal Industries, Inc. | 1998-08-11 | 27 | 1 |
| K974763 | DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA | Deroyal Industries, Inc. | 1998-07-10 | 203 | 0 |
| K980509 | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS | Deroyal Industries, Inc. | 1998-02-26 | 16 | 0 |
| K972693 | DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR | Deroyal Industries, Inc. | 1997-09-30 | 74 | 0 |
| K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL | Deroyal Industries, Inc. | 1997-05-22 | 64 | 0 |
| K963466 | PEDIATRIC LIMB HOLDER | Deroyal Industries, Inc. | 1997-02-13 | 163 | 0 |
| K963479 | WHEELCHAIR BELT | Deroyal Industries, Inc. | 1997-01-24 | 143 | 0 |
| K963474 | TUXEDO VEST RESTRAINT | Deroyal Industries, Inc. | 1997-01-22 | 141 | 0 |
| K963468 | RESTRICTIVE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 | 141 | 0 |
| K963480 | MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER | Deroyal Industries, Inc. | 1997-01-22 | 141 | 0 |
| K963476 | DISPOSABLE LIMB HOLDER | Deroyal Industries, Inc. | 1997-01-22 | 141 | 1 |
| K963475 | PONCHO VEST RESTRAINT | Deroyal Industries, Inc. | 1997-01-22 | 141 | 0 |
| K963467 | ROLL BELTS | Deroyal Industries, Inc. | 1997-01-03 | 122 | 0 |
| K963465 | PELVIC HOLDER | Deroyal Industries, Inc. | 1996-12-19 | 107 | 0 |
| K963472 | PEDIATRIC VEST RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | 72 | 0 |
| K963469 | MITTENS | Deroyal Industries, Inc. | 1996-11-14 | 72 | 0 |
| K963471 | SUPER SECURITY RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | 72 | 0 |
| K963478 | SLEEVED/SLEEVELESS VEST RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | 72 | 0 |
| K963473 | REUSABLE LIMB HOLDER | Deroyal Industries, Inc. | 1996-11-14 | 72 | 0 |
| K963470 | CRISS-CROSS VEST RESTRAINT | Deroyal Industries, Inc. | 1996-11-14 | 72 | 0 |
| K963477 | PEDIATRIC MITTENS | Deroyal Industries, Inc. | 1996-11-12 | 70 | 0 |
| K963464 | RESTRAINT NET | Deroyal Industries, Inc. | 1996-11-12 | 70 | 0 |
| K963463 | STRAIT JACKET | Deroyal Industries, Inc. | 1996-10-16 | 43 | 0 |
| K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL | Deroyal Industries, Inc. | 1996-10-08 | 161 | 0 |
| K950565 | DEROYAL SURGICAL INSTRUMENT DRAPE | Deroyal Industries, Inc. | 1995-12-13 | 308 | 0 |
| K952775 | DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING | Deroyal Industries, Inc. | 1995-10-06 | 112 | 0 |
| K953403 | DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOU | Deroyal Industries, Inc. | 1995-10-06 | 78 | 0 |
| K953953 | DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF | Deroyal Industries, Inc. | 1995-09-29 | 38 | 0 |
| K953952 | DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF | Deroyal Industries, Inc. | 1995-09-28 | 37 | 0 |
| K951178 | UROLOGICAL CATHETER & ACCESSORIES | Deroyal Industries, Inc. | 1995-04-21 | 37 | 0 |
| K945789 | DEROYAL DISPOSABLE INSUFFLATION TUBING FILTER | Deroyal Industries, Inc. | 1995-02-07 | 74 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda