Cleared Traditional

K972498 - OBSERVER * CENTRAL STATION

K972498 is the FDA 510(k) clearance for OBSERVER * CENTRAL STATION by Johnson & Johnson Medical, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K972498 · Johnson & Johnson Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
229d
Days
Class 2
Risk

K972498 is an FDA 510(k) clearance for the OBSERVER * CENTRAL STATION. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Johnson & Johnson Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on February 17, 1998 after a review of 229 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number K972498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1997
Decision Date February 17, 1998
Days to Decision 229 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
104d slower than avg
Panel avg: 125d · This submission: 229d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 220
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K972498.
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
K972502 · Spacelabs Medical, Inc. · May 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · Siemens Medical Solutions USA, Inc. · May 1998
ENVOY PATIENT MONITOR
K974510 · Mennen Medical, Inc. · Apr 1998
ENSEMBLE CENTRAL STATION MONITOR
K970358 · Mennen Medical, Inc. · Feb 1998
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714 · Siemens Medical Solutions USA, Inc. · Oct 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131 · Fukuda Denshi USA, Inc. · Oct 1997