Cleared Traditional

K952969 - EIDOS 5003 HOLTER SYSTEM

K952969 is an FDA 510(k) clearance for EIDOS 5003 HOLTER SYSTEM, manufactured by New Product Development, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K952969 · New Product Development, Inc. · Cardiovascular device
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Jul 1996
Decision
385d
Days
Class 2
Risk

K952969 is an FDA 510(k) clearance for the EIDOS 5003 HOLTER SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by New Product Development, Inc. (East Syracuse, US). The FDA issued a Cleared decision on July 16, 1996 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 New Product Development, Inc. devices

FDA 510(k) Submission Details - K952969

510(k) Number K952969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1995
Decision Date July 16, 1996
Days to Decision 385 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 125d · This submission: 385d
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 360
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K952969.
BIOSENSOR HOLTER MONITOR SYSTEM
K974546 · Biosensor Corp. · Mar 1998
NIVP3 (WINDOWS VERSION OF NIVP
K970570 · D. E. Hokanson, Inc. · Oct 1997
SPACELABS MEDICAL ECG ANALYSIS SYSTEM
K962930 · Spacelabs Medical, Inc. · Apr 1997
PATHFINDER 700 HOLTER ANALYZER
K951902 · Reynolds Medical , Ltd. · Jul 1996
AMBULATORY (HOLTER) RECORDING SYSTEM
K950944 · Biosensor Corp. · Jun 1996
STRESSWRITER EXERCISE TESTING SYSTEM
K961009 · Hewlett-Packard Co. · Jun 1996