Cleared Traditional

K955015 - ZYMED HOLTER SCANNER MODEL 2010

K955015 is an FDA 510(k) clearance for ZYMED HOLTER SCANNER MODEL 2010, manufactured by Zymed Medical Instrumentation. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K955015 · Zymed Medical Instrumentation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
138d
Days
Class 2
Risk

K955015 is an FDA 510(k) clearance for the ZYMED HOLTER SCANNER MODEL 2010. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Zymed Medical Instrumentation (Camarillo, US). The FDA issued a Cleared decision on March 18, 1996 after a review of 138 days - within the typical 510(k) review window.

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 Zymed Medical Instrumentation devices

FDA 510(k) Submission Details - K955015

510(k) Number K955015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date March 18, 1996
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
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 331
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K955015.
AMBULATORY (HOLTER) RECORDING SYSTEM
K950944 · Biosensor Corp. · Jun 1996
STRESSWRITER EXERCISE TESTING SYSTEM
K961009 · Hewlett-Packard Co. · Jun 1996
AS/3 CARDIAC OUTPUT & SVO2 MODULE
K961063 · Datex Medical Instrumentation, Inc. · May 1996
ACCUSTRESS EXERCISE TESTING SYSTEM
K953127 · Hewlett-Packard Co. · Feb 1996
RESPIEVENTS
K942771 · Non-Invasive Monitoring Systems, Inc. · Feb 1996
RESPITRACE PT
K942852 · Non-Invasive Monitoring Systems, Inc. · Feb 1996