Cleared Traditional

K942650 - BIG BEN

K942650 is an FDA 510(k) clearance for BIG BEN, manufactured by Rud Riester GmbH & CO KG. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K942650 · Rud Riester GmbH & CO KG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
76d
Days
Class 2
Risk

K942650 is an FDA 510(k) clearance for the BIG BEN. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Rud Riester GmbH & CO KG (Jungingen, DE). The FDA issued a Cleared decision on August 15, 1994 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Rud Riester GmbH & CO KG devices

FDA 510(k) Submission Details - K942650

510(k) Number K942650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date August 15, 1994
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 912
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K942650.
NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER
K945947 · Nellcor, Inc. · Mar 1995
TRIMLINE 2000
K943081 · Pymah Corp. · Jan 1995
NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)
K941167 · Spacelabs Medical, Inc. · Nov 1994
MINIPACK 3100/3000 MODIFICATION
K934385 · Pace Tech, Inc. · Aug 1994
DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
K935782 · Ohmeda Medical · Aug 1994
EXACTA-SPEZIAL
K925295 · Rudolf Riester GmbH & Co. KG · Mar 1994