Cleared Traditional

K912281 - ES1600 PARAMEDIC TELEPHONE

K912281 is an FDA 510(k) clearance for ES1600 PARAMEDIC TELEPHONE, manufactured by Epic Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K912281 · Epic Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
180d
Days
Class 2
Risk

K912281 is an FDA 510(k) clearance for the ES1600 PARAMEDIC TELEPHONE. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Epic Systems, Inc. (Darby, US). The FDA issued a Cleared decision on November 19, 1991 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Epic Systems, Inc. devices

FDA 510(k) Submission Details - K912281

510(k) Number K912281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1991
Decision Date November 19, 1991
Days to Decision 180 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 195
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K912281.
CARDIOMAGIC SOFTWARE
K925639 · Instromedix, Inc. · Jun 1993
KING OF HEARTS EXPRESS (E.X.) MONITOR
K920984 · Instromedix, Inc. · Oct 1992
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR
K915769 · Medtronic Vascular · Jan 1992
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)
K913533 · Hewlett-Packard Co. · Nov 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · Medtronic Vascular · Jul 1991
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379 · Cardiac Pacemakers, Inc. · Jun 1991