Cleared Traditional

K953127 - ACCUSTRESS EXERCISE TESTING SYSTEM

K953127 is an FDA 510(k) clearance for ACCUSTRESS EXERCISE TESTING SYSTEM, manufactured by Hewlett-Packard Co.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K953127 · Hewlett-Packard Co. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
239d
Days
Class 2
Risk

K953127 is an FDA 510(k) clearance for the ACCUSTRESS EXERCISE TESTING SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 239 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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

FDA 510(k) Submission Details - K953127

510(k) Number K953127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1995
Decision Date February 29, 1996
Days to Decision 239 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
114d slower than avg
Panel avg: 125d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 374
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K953127.
STRESSWRITER EXERCISE TESTING SYSTEM
K961009 · Hewlett-Packard Co. · Jun 1996
AS/3 CARDIAC OUTPUT & SVO2 MODULE
K961063 · Datex Medical Instrumentation, Inc. · May 1996
ZYMED HOLTER SCANNER MODEL 2010
K955015 · Zymed Medical Instrumentation · Mar 1996
RESPIEVENTS
K942771 · Non-Invasive Monitoring Systems, Inc. · Feb 1996
RESPITRACE PT
K942852 · Non-Invasive Monitoring Systems, Inc. · Feb 1996
AMBULATORY (HOLTER) RECORDING SYSTEM
K950723 · Biosensor Corp. · Feb 1996