Cleared Traditional

K991545 - WATCH STYLE WRIST DIGITAL BLOOD PRESSUR...

K991545 is the FDA 510(k) clearance for WATCH STYLE WRIST DIGITAL BLOOD PRESSUR... by Industrielle Entwicklung Medizintechnik Und Vertri. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K991545 · Industrielle Entwicklung Medizintechnik Und Vertri · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
261d
Days
Class 2
Risk

K991545 is an FDA 510(k) clearance for the WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Industrielle Entwicklung Medizintechnik Und Vertri (Bonita Springs, US). The FDA issued a Cleared decision on January 19, 2000 after a review of 261 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Industrielle Entwicklung Medizintechnik Und Vertri devices

Submission Details

510(k) Number K991545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1999
Decision Date January 19, 2000
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
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 74
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K991545.
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
K022482 · Ge Medical Systems Information Technologies · Aug 2002
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · Welch Allyn, Inc. · Aug 2001
CLEEN-ABLE
K994044 · Vital Signs, Inc. · Feb 2000
CUFF-ABLE PLUS
K990412 · Vital Signs, Inc. · Sep 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · Deroyal Industries, Inc. · Jul 1999
CRITIKON SOFT BLOOD PRESSURE CUFF
K974080 · Johnson & Johnson Medical, Inc. · May 1998