Submission Details
| 510(k) Number | K991525 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1999 |
| Decision Date | July 20, 1999 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
Jul 1999
Decision
78d
Days
Class 2
Risk
About This 510(k) Submission
K991525 is an FDA 510(k) clearance for the DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF, a Blood Pressure Cuff (Class II — Special Controls, product code DXQ), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on July 20, 1999, 78 days after receiving the submission on May 3, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1120.
Device Classification
| Product Code | DXQ — Blood Pressure Cuff |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1120 |
| Definition | A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure. |
Manufacturer
Similar Devices — DXQ Blood Pressure Cuff
All 196
K253089 · Shenzhen Best Electronics Co., Ltd.
· Feb 2026
K253964 · Unimed Medical Supplies, Inc.
· Jan 2026
K251745 · Baxter Healthcare Corporation
· Dec 2025
K250765 · Avita Corporation
· Sep 2025
K251045 · Unimed Medical Supplies, Inc.
· Jul 2025
K242623 · Shenzhen Medke Technology Co., Ltd.
· Oct 2024
More from Deroyal Industries, Inc.
View all
K250586
· OMP · Nov 2025
K230233
· OMP · Apr 2024
K200631
· FLL · Dec 2020
K200757
· EYC · Oct 2020
K193027
· BZT · Apr 2020