Cleared Traditional

K961401 - HP CATHSTATION - MODEL M1264B

K961401 is the FDA 510(k) clearance for HP CATHSTATION - MODEL M1264B by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

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 265
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K961401.
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
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NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
K963400 · Nellcor Puritan Bennett, Inc. · Nov 1996
AS/3 LIGHT MONITOR
K961247 · Datex Division Instrumentarium Corp. · Oct 1996
DINAMAP SELECT MULTI-PARAMETER SYSTEM
K955113 · Johnson & Johnson Medical, Inc. · Aug 1996
CARDIMAX MODEL FX-2111
K955416 · Fukuda Denshi USA, Inc. · Jul 1996
NELLCOR SYMPHONY N-3000 PATIENT MONITOR W/SP02 & ECG/N-3200 DISPLAY/PRINTER
K955642 · Nellcor Puritan Bennett, Inc. · Jul 1996