Cleared Traditional

K970305 - PRINTER INTERFACE

K970305 is an FDA 510(k) clearance for PRINTER INTERFACE, manufactured by Micromedical, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K970305 · Micromedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
200d
Days
Class 2
Risk

K970305 is an FDA 510(k) clearance for the PRINTER INTERFACE. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Micromedical, Inc. (Northbrook, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 200 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 Micromedical, Inc. devices

FDA 510(k) Submission Details - K970305

510(k) Number K970305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1997
Decision Date August 15, 1997
Days to Decision 200 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
75d slower than avg
Panel avg: 125d · This submission: 200d
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 135
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K970305.
RHYTHMSTAT XL
K971650 · Data Critical Corp. · Dec 1997
CARDIOCALL CARDIAC EVENT RECORDER
K972649 · Reynolds Medical , Ltd. · Dec 1997
HEART ACCESS PLUS CARDIAC EVENT RECORDER
K973141 · Paceart, Inc. · Nov 1997
CARD GUARD, MODEL CG-7100
K964836 · Card Guard Scientific Survival , Ltd. · Jul 1997
CARDIOMAGIC 2000 SOFTWARE
K964036 · Instromedix, Inc. · Jul 1997
CARDIOBEEPER CB-12L
K965101 · Meridian Medical Technologies, Inc. · Mar 1997