Cleared Traditional

K945947 - NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER

K945947 is an FDA 510(k) clearance for NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESS..., manufactured by Nellcor, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K945947 · Nellcor, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
92d
Days
Class 2
Risk

K945947 is an FDA 510(k) clearance for the NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLC.... Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Nellcor, Inc. (Lenexa, US). The FDA issued a Cleared decision on March 8, 1995 after a review of 92 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K945947

510(k) Number K945947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1994
Decision Date March 08, 1995
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
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 1054
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K945947.
ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS
K942543 · Sankei Co., Ltd. · Jul 1995
DYNAPULSE 5000A (DP5000A)
K945111 · Pulse Metric, Inc. · Jun 1995
MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND
K942072 · Mabis Healthcare, Inc. · May 1995
PANASONIC WRIST BLOOD PRESSURE METER
K942422 · King & Spalding · Feb 1995
NAIS WRIST BLOOD PRESSURE METER
K942423 · King & Spalding · Feb 1995
VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205
K950249 · Medwave, Inc. · Feb 1995
K945947 · NELLCOR SYMPHONY(TM) N-3100 BLOOD PRESSURE MONITOR AND CONNECTED TO THE NELLCOR SYMPHONY(TM) N-3000 PULSE OXIMETER
Download PDF FDA Summary Nellcor, Inc.