Cleared Traditional

HP CATHSTATION - MODEL M1264B (K961401) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961401 · Hewlett-Packard Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
180d
Days
Class 2
Risk

K961401 is an FDA 510(k) clearance for the HP CATHSTATION - MODEL M1264B. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on October 8, 1996 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K961401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1996
Decision Date October 08, 1996
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 118
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K961401.
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
K972310 · Nihon Kohden America, Inc. · Aug 1997
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · Quinton, Inc. · Aug 1997
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · Hewlett-Packard Co. · Aug 1995
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
K945626 · Quinton, Inc. · Jun 1995
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994