Cleared Traditional

K991525 - DEROYAL STERILE NEONATAL BLOOD PRESSURE...

K991525 is the FDA 510(k) clearance for DEROYAL STERILE NEONATAL BLOOD PRESSURE... by Deroyal Industries, Inc.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K991525 · Deroyal Industries, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
78d
Days
Class 2
Risk

K991525 is an FDA 510(k) clearance for the DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on July 20, 1999 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K991525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 78
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K991525.
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · Cas Medical Systems, Inc. · Sep 2000
CLEEN-ABLE
K994044 · Vital Signs, Inc. · Feb 2000
CUFF-ABLE PLUS
K990412 · Vital Signs, Inc. · Sep 1999
CRITIKON SOFT BLOOD PRESSURE CUFF
K974080 · Johnson & Johnson Medical, Inc. · May 1998
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · American Diagnostic Corp. · Jan 1997
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · Deroyal Industries, Inc. · Sep 1995