Cleared Traditional

HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING (K921194) - FDA 510(k) Clearance

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

K921194 · Hewlett-Packard Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
242d
Days
Class 2
Risk

K921194 is an FDA 510(k) clearance for the HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on November 9, 1992 after a review of 242 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 K921194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date November 09, 1992
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 54
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K921194.
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2004
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · Nihon Kohden America, Inc. · Jan 1998
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · Hewlett-Packard Co. · Jun 1991
WEP-8430A TELEMETRY CENTRAL STATION
K904696 · Nihon Kohden America, Inc. · Feb 1991
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990