Cleared Traditional

HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A (K961165) - FDA 510(k) Clearance

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

K961165 · Hewlett-Packard Co. · Cardiovascular device
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Oct 1996
Decision
199d
Days
Class 2
Risk

K961165 is an FDA 510(k) clearance for the HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on October 10, 1996 after a review of 199 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K961165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1996
Decision Date October 10, 1996
Days to Decision 199 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
74d slower than avg
Panel avg: 125d · This submission: 199d
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 93
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K961165.
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K962291 · Siemens Medical Solutions USA, Inc. · Jan 1997
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K962404 · Siemens Medical Solutions USA, Inc. · Jan 1997
HP STAR ST AND ARRHHYTHMIA SOFTWARE
K964122 · Hewlett-Packard Co. · Jan 1997
SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
K955743 · Siemens Medical Solutions USA, Inc. · Jul 1996
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
K952054 · Siemens Medical Solutions USA, Inc. · Jun 1996
OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER
K955059 · Siemens Medical Solutions USA, Inc. · Jun 1996