Cleared Traditional

K880357 - OMNIGRAPH 6000

K880357 is an FDA 510(k) clearance for OMNIGRAPH 6000, manufactured by Telemed Div.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K880357 · Telemed Div. · Cardiovascular device
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Aug 1988
Decision
187d
Days
Class 2
Risk

K880357 is an FDA 510(k) clearance for the OMNIGRAPH 6000. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Telemed Div. (Hoffman Estates, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 187 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Telemed Div. devices

FDA 510(k) Submission Details - K880357

510(k) Number K880357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1988
Decision Date August 02, 1988
Days to Decision 187 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 436
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K880357.
OEC-7102 ECG/NIBP MONITOR
K882254 · Nihon Kohden America, Inc. · Nov 1988
ECG MONITOR AND RESPIRATION PACER
K881055 · D. E. Hokanson, Inc. · Aug 1988
MINIMON 7131B PATIENT MONITOR
K882197 · Kontron Instruments, Inc. · Aug 1988
MINIMON 7132B PATIENT MONITOR
K882198 · Kontron Instruments, Inc. · Jul 1988
MODEL 375 ECG
K881328 · Birtcher Corp. · May 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · Mennen Medical, Inc. · May 1988