Cleared Traditional

K930558 - MORTARA INSTRUMENT, INC. E-SCRIBE (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930558 · Mortara Instrument, Inc. · Cardiovascular device
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.

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
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · 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 14
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K930558.
MAC 7 Resting ECG Analysis System
K251670 · Ge Medical Systems Information Technologies, Inc. · Jan 2026
AccurECG Analysis System (v2.0)
K252361 · Accurkardia, Inc. · Dec 2025
Withings BeamO (SCT02)
K252474 · Withings · Nov 2025
Cardiologs Holter Platform
K250569 · Philips France Commercial · Aug 2025
ZBPro Diagnostic
K243252 · Zbeats, Inc. · Jul 2025
Masimo W1
K243305 · Masimo Corporation · Apr 2025