Cleared Traditional

K002955 - EMPIRE N BLOOD PRESSURE MANOMETERS

K002955 is an FDA 510(k) clearance for EMPIRE N BLOOD PRESSURE MANOMETERS, manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002955 · Rudolf Riester GmbH & Co. KG · Cardiovascular device
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Dec 2000
Decision
90d
Days
Class 2
Risk

K002955 is an FDA 510(k) clearance for the EMPIRE N BLOOD PRESSURE MANOMETERS. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Rudolf Riester GmbH & Co. KG (Jungingen, DE). The FDA issued a Cleared decision on December 21, 2000 after a review of 90 days - within the typical 510(k) review window.

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 Rudolf Riester GmbH & Co. KG devices

FDA 510(k) Submission Details - K002955

510(k) Number K002955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date December 21, 2000
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K002955.
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
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
K002954 · Rudolf Riester GmbH & Co. KG · Dec 2000
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