Deroyal Industries, Inc.: FDA filings under this applicant name
FDA lists 92 510(k) clearances under the applicant name “Deroyal Industries, Inc.” (first 1984, latest 2025), across 45 product codes in 9 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 205 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 79 |
| 2014 | 1 | 273 |
| 2015 | 1 | 282 |
| 2016 | 1 | 168 |
| 2017 | 1 | 90 |
| 2018 | 1 | 187 |
| 2019 | 0 | — |
| 2020 | 5 | 205 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 447 |
| 2025 | 1 | 267 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Deroyal Industries, Inc. took a median 205 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMQ | Restraint, Protective | 15 | 15 |
| KKX | Drape, Surgical, Antimicrobial | 11 | 11 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| FMT | Warmer, Infant Radiant | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| KGX | Tape And Bandage, Adhesive | 3 | 3 |
| KID | Restraint, Wheelchair, Non-Protective | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
Plus 35 more product codes.
Review panels
- General Hospital (37)
- General and Plastic Surgery (27)
- Cardiovascular (6)
- Gastroenterology and Urology (5)
- Physical Medicine (4)
- Anesthesiology (3)
- Obstetrics and Gynecology (3)
- Orthopedic (3)
- Ophthalmic (2)
Most recent Deroyal Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory | OMP | 2025-11-21 | 267 |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | OMP | 2024-04-18 | 447 |
| K200631 | DeRoyal Temperature Monitoring Probe | FLL | 2020-12-23 | 288 |
| K200757 | Foley Catheter with Temperature Sensor | EYC | 2020-10-15 | 205 |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable | FMT | 2020-04-02 | 55 |
| K193027 | Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French | BZT | 2020-04-02 | 155 |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe Cover | FMT | 2020-01-21 | 237 |
| K173072 | Algidex Ag Silver Alginate Wound Dressing | FRO | 2018-04-04 | 187 |
| K171475 | DeRoyal Laprador Specimen Retrieval System | GCJ | 2017-08-17 | 90 |
| K152978 | DeRoyal Angiography Kits | DXT | 2016-03-25 | 168 |
82 earlier clearances. See the full list in Caduvo.
Recalls
236 product recalls in 52 recall events; 182 initiated in the last five years. Most recent: 2026-08-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Deroyal Industries, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05559697: Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days (Completed, started 2024-02-26)
- NCT05610241: Preliminary Investigation of a Smart Compression Therapy Prototype (Completed, started 2023-03-04)
- NCT02811965: Evaluation of Heel Offloading Devices for Reducing Heel Contact Pressures in Healthy Volunteers (Completed, started 2016-06)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Deroyal (5 510(k)s)
- Deroyal Cardiovascular, Inc. (1 510(k)s)
- Deroyal Critical Care, Div. Deroyal Technologies (1 510(k)s)
- Deroyal Surgical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Deroyal Industries, Inc.?
FDA lists 92 510(k) clearances under the applicant name “Deroyal Industries, Inc.” (first 1984, latest 2025), across 45 product codes in 9 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Deroyal Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Deroyal Industries, Inc. is 90 days. Since 2017: 205 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Deroyal Industries, Inc.?
The most frequent FDA product codes under this applicant name are FMQ (Restraint, Protective, 15); KKX (Drape, Surgical, Antimicrobial, 11); BZT (Stethoscope, Esophageal, With Electrical Conductors, 3).
Next steps
- See all 92 Deroyal Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMQ, Deroyal Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.