Cleared Traditional

K930558 - MORTARA INSTRUMENT

K930558 is the FDA 510(k) clearance for MORTARA INSTRUMENT by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K930558 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
83d
Days
Class 2
Risk

K930558 is an FDA 510(k) clearance for the MORTARA INSTRUMENT, INC. E-SCRIBE. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 27, 1993 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mortara Instrument, Inc. devices

Submission Details

510(k) Number K930558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1993
Decision Date April 27, 1993
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 220
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K930558.
MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
K935394 · Marquette Electronics, Inc. · Oct 1994
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994
CRITIKON CENTRAL STATIN MONITOR
K933404 · Critikon Company, LLC · Feb 1994
9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT
K930134 · S & W Medico Teknik · Apr 1993
MORTARA INSTRUMENT ST CENTRAL STATION
K922927 · Mortara Instrument, Inc. · Nov 1992
TYPE 9050/NEO
K912183 · S & W Medico Teknik · Jun 1992