Cleared Traditional

K950988 - HOLTER 6000

K950988 is an FDA 510(k) clearance for HOLTER 6000, manufactured by Omega Medical Services, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K950988 · Omega Medical Services, Inc. · Cardiovascular device
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Jan 1996
Decision
307d
Days
Class 2
Risk

K950988 is an FDA 510(k) clearance for the HOLTER 6000. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Omega Medical Services, Inc. (Fort Myers, US). The FDA issued a Cleared decision on January 4, 1996 after a review of 307 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 Omega Medical Services, Inc. devices

FDA 510(k) Submission Details - K950988

510(k) Number K950988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date January 04, 1996
Days to Decision 307 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
182d slower than avg
Panel avg: 125d · This submission: 307d
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 332
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K950988.
RESPITRACE PT
K942852 · Non-Invasive Monitoring Systems, Inc. · Feb 1996
AMBULATORY (HOLTER) RECORDING SYSTEM
K950723 · Biosensor Corp. · Feb 1996
OMEGA CARES SYSTEM
K945068 · J-F Medical Systems Intl., Inc. · Jan 1996
EPICARDIA
K952846 · Medicomp, Inc. · Sep 1995
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
K941762 · Hogan & Hartson · Feb 1995
ALTAIR-DISC RECORDER
K942565 · Burdick Corp. · Dec 1994