Medical device manufacturer
DeRoyal Industries Inc
DeRoyal Industries Inc holds 92 FDA 510(k) clearances across 44 product codes. Median elapsed review time is 90 days. openFDA lists 235 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 92
- Product codes
- 44
- Median review
- 90 days
- Recall records
- 235
How does FDA spell DeRoyal Industries Inc?
FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| DEROYAL INDUSTRIES, INC. | device/registrationlisting | normalised |
| DeRoyal Industries Inc | device/enforcement | normalised |
| DeRoyal Industries Inc | device/recall | normalised |
| DeRoyal Industries, Inc. | device/registrationlisting | normalised |
| Deroyal Industries | device/510k | normalised |
| Deroyal Industries, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does DeRoyal Industries Inc file in?
44 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FMQ | Restraint, Protective | 15 | 72 days | |
| KKX | Drape, Surgical, Antimicrobial | 11 | 62 days | |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 3 | 202 days | |
| FLL | Continuous Measurement Thermometer | 3 | 466 days | |
| FMT | Warmer, Infant Radiant | 3 | 237 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 79 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 79 days | |
| KGX | Tape And Bandage, Adhesive | 3 | 65 days | |
| KID | Restraint, Wheelchair, Non-Protective | 3 | 141 days | |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 236 days | |
| DXQ | Blood Pressure Cuff | 2 | 37 days | |
| EYC | Catheter, Upper Urinary Tract | 2 | 182 days | |
| FRO | Dressing, Wound, Drug | 2 | 187 days | |
| HIF | Insufflator, Laparoscopic | 2 | 74 days | |
| HRS | Plate, Fixation, Bone | 2 | 90 days | |
| MDM | Instrument, Manual, Surgical, General Use | 2 | 9 days | |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 2 | 267 days | |
| DQY | Catheter, Percutaneous | 1 | 48 days | |
| DWD | Suction Control, Intracardiac, Cardiopulmonary Bypass | 1 | 136 days | |
| DXT | Injector And Syringe, Angiographic | 1 | 168 days | |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 37 days | |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 38 days | |
| FRG | Wrap, Sterilization | 1 | 121 days | |
| FYA | Gown, Surgical | 1 | 83 days | |
| GAG | Stapler, Surgical | 1 | 214 days |
Showing the 25 they file in most, of 44.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has DeRoyal Industries Inc had a recall?
openFDA lists 235 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2305-2026Class IIOpen, ClassifiedNAC
Sterile wound dressing, lacks sterility assurance
Z-1291-2025Class IIOpen, ClassifiedGAZ
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
Z-1174-2025Class IIOpen, ClassifiedBYY
The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.
Z-0306-2025Class IIOpen, ClassifiedKDD
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Z-0307-2025Class IIOpen, ClassifiedLRO
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Showing the 5 most recently initiated of 235.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has DeRoyal Industries Inc cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | OMP | 267 | |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | OMP | 447 | |
| K200631 | DeRoyal Temperature Monitoring Probe | FLL | 288 | |
| K200757 | Foley Catheter with Temperature Sensor | EYC | 205 | |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | FMT | 55 | |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | BZT | 155 | |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | FMT | 237 | |
| K173072 | Algidex Ag Silver Alginate Wound Dressing | FRO | 187 | |
| K171475 | DeRoyal Laprador Specimen Retrieval System | GCJ | 90 | |
| K152978 | DeRoyal Angiography Kits | DXT | 168 |
Source: openFDA device/510k · retrieved
Where is DeRoyal Industries Inc registered?
FDA lists 9 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what DeRoyal Industries Inc files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.